naloxone-hydrochloride


Name: NALOXONE HYDROCHLORIDE
ID :
MW: 327
Number of atoms: 24
Molecular_Formula: C19H21NO4
Alogp: 1.453
Indication class : Antagonist (to narcotics)
Oral Flag : 1
Max_Phase : 4
Molecule_Type : Small molecule

naloxone hydrochloride containing products summary

There are in total 83 different products containing the active ingredient naloxone hydrochloride. From the 83 drug products, 53 have been discontinued.

Product id = 9602
Application Number = 16636
Date of Application = Prior, Approved, to
RX/OTC/DISCN = DISCN
Tradename = NARCAN
Route/format = INJECTION / INJECTABLE
Application Type = N
Applicant Name = ENDO PHARMS
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
----
Product id = 9601
Application Number = 16636
Date of Application = Prior, Approved, to
RX/OTC/DISCN = DISCN
Tradename = NARCAN
Route/format = INJECTION / INJECTABLE
Application Type = N
Applicant Name = ENDO PHARMS
ProductNo = 002
Tecode =
Rld = No
Strength = 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
----
Product id = 9603
Application Number = 16636
Date of Application = 14,, Jun, 1982
RX/OTC/DISCN = DISCN
Tradename = NARCAN
Route/format = INJECTION / INJECTABLE
Application Type = N
Applicant Name = ENDO PHARMS
ProductNo = 003
Tecode =
Rld = No
Strength = 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
----
Product id = 28446
Application Number = 18733
Date of Application = 16,, Dec, 1982
RX/OTC/DISCN = DISCN
Tradename = TALWIN NX
Route/format = ORAL / TABLET
Application Type = N
Applicant Name = SANOFI AVENTIS US
ProductNo = 001
Tecode =
Rld = No
Strength = EQ 0.5MG BASE;EQ 50MG BASE
----
Product id = 30213
Application Number = 20733
Date of Application = 8,, Oct, 2002
RX/OTC/DISCN = DISCN
Tradename = SUBOXONE
Route/format = SUBLINGUAL / TABLET
Application Type = N
Applicant Name = RECKITT BENCKISER
ProductNo = 001
Tecode =
Rld = No
Strength = EQ 2MG BASE;EQ 0.5MG BASE
----
Product id = 30214
Application Number = 20733
Date of Application = 8,, Oct, 2002
RX/OTC/DISCN = DISCN
Tradename = SUBOXONE
Route/format = SUBLINGUAL / TABLET
Application Type = N
Applicant Name = RECKITT BENCKISER
ProductNo = 002
Tecode =
Rld = No
Strength = EQ 8MG BASE;EQ 2MG BASE
----
Product id = 4801
Application Number = 22410
Date of Application = 30,, Aug, 2010
RX/OTC/DISCN = RX
Tradename = SUBOXONE
Route/format = SUBLINGUAL / FILM
Application Type = N
Applicant Name = RECKITT BENCKISER
ProductNo = 001
Tecode =
Rld = No
Strength = EQ 2MG BASE;EQ 0.5MG BASE
----
Product id = 4803
Application Number = 22410
Date of Application = 30,, Aug, 2010
RX/OTC/DISCN = RX
Tradename = SUBOXONE
Route/format = SUBLINGUAL / FILM
Application Type = N
Applicant Name = RECKITT BENCKISER
ProductNo = 002
Tecode =
Rld = No
Strength = EQ 8MG BASE;EQ 2MG BASE
----
Product id = 4802
Application Number = 22410
Date of Application = 10,, Aug, 2012
RX/OTC/DISCN = RX
Tradename = SUBOXONE
Route/format = SUBLINGUAL / FILM
Application Type = N
Applicant Name = RECKITT BENCKISER
ProductNo = 003
Tecode =
Rld = No
Strength = EQ 4MG BASE;EQ 1MG BASE
----
Product id = 4804
Application Number = 22410
Date of Application = 10,, Aug, 2012
RX/OTC/DISCN = RX
Tradename = SUBOXONE
Route/format = SUBLINGUAL / FILM
Application Type = N
Applicant Name = RECKITT BENCKISER
ProductNo = 004
Tecode =
Rld = Yes
Strength = EQ 12MG BASE;EQ 3MG BASE
----
Product id = 9566
Application Number = 70171
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HOSPIRA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9569
Application Number = 70172
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HOSPIRA
ProductNo = 001
Tecode = AP
Rld = Yes
Strength = 0.4MG/ML
----
Product id = 9541
Application Number = 70188
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = WYETH AYERST
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9542
Application Number = 70189
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = WYETH AYERST
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9543
Application Number = 70190
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = WYETH AYERST
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9544
Application Number = 70191
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = WYETH AYERST
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9567
Application Number = 70252
Date of Application = 16,, Jan, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HOSPIRA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9568
Application Number = 70253
Date of Application = 16,, Jan, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HOSPIRA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9570
Application Number = 70254
Date of Application = 7,, Jan, 1987
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HOSPIRA
ProductNo = 001
Tecode = AP
Rld = Yes
Strength = 0.4MG/ML
----
Product id = 9571
Application Number = 70255
Date of Application = 7,, Jan, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HOSPIRA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9572
Application Number = 70256
Date of Application = 7,, Jan, 1987
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HOSPIRA
ProductNo = 001
Tecode = AP
Rld = Yes
Strength = 0.4MG/ML
----
Product id = 9573
Application Number = 70257
Date of Application = 7,, Jan, 1987
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HOSPIRA
ProductNo = 001
Tecode = AP
Rld = Yes
Strength = 0.4MG/ML
----
Product id = 9538
Application Number = 70298
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HIKMA MAPLE
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9539
Application Number = 70299
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HIKMA MAPLE
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9574
Application Number = 70417
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = INTL MEDICATION
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9540
Application Number = 70496
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HIKMA MAPLE
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9575
Application Number = 70639
Date of Application = 24,, Sep, 1986
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = INTL MEDICATION
ProductNo = 001
Tecode = AP
Rld = No
Strength = 0.4MG/ML
----
Product id = 9545
Application Number = 70648
Date of Application = 17,, Nov, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ABRAXIS PHARM
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9547
Application Number = 70649
Date of Application = 17,, Nov, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ABRAXIS PHARM
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9546
Application Number = 70661
Date of Application = 17,, Nov, 1986
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ABRAXIS PHARM
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9598
Application Number = 71083
Date of Application = 28,, Jul, 1988
RX/OTC/DISCN = DISCN
Tradename = NARCAN
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = BRISTOL MYERS SQUIBB
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9599
Application Number = 71084
Date of Application = 28,, Jul, 1988
RX/OTC/DISCN = DISCN
Tradename = NARCAN
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = BRISTOL MYERS SQUIBB
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9562
Application Number = 71272
Date of Application = 24,, May, 1988
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HIKMA MAPLE
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9563
Application Number = 71273
Date of Application = 24,, May, 1988
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HIKMA MAPLE
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9564
Application Number = 71274
Date of Application = 24,, May, 1988
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HIKMA MAPLE
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9565
Application Number = 71287
Date of Application = 24,, May, 1988
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = HIKMA MAPLE
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9600
Application Number = 71311
Date of Application = 28,, Jul, 1988
RX/OTC/DISCN = DISCN
Tradename = NARCAN
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = BRISTOL MYERS SQUIBB
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9585
Application Number = 71339
Date of Application = 18,, Nov, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = WATSON LABS
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9548
Application Number = 71604
Date of Application = 16,, Dec, 1988
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ABRAXIS PHARM
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9580
Application Number = 71671
Date of Application = 17,, Nov, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = SMITH AND NEPHEW
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9583
Application Number = 71672
Date of Application = 17,, Nov, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = SOLOPAK
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9581
Application Number = 71681
Date of Application = 17,, Nov, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = SMITH AND NEPHEW
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9582
Application Number = 71682
Date of Application = 17,, Nov, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = SMITH AND NEPHEW
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9584
Application Number = 71683
Date of Application = 17,, Nov, 1987
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = SOLOPAK
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9578
Application Number = 71811
Date of Application = 19,, Jul, 1988
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = MARSAM PHARMS LLC
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9576
Application Number = 72076
Date of Application = 24,, Mar, 1988
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = INTL MEDICATION
ProductNo = 001
Tecode = AP
Rld = Yes
Strength = 1MG/ML
----
Product id = 9549
Application Number = 72081
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9550
Application Number = 72082
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9551
Application Number = 72083
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9552
Application Number = 72084
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9553
Application Number = 72085
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.02MG/ML
----
Product id = 9554
Application Number = 72086
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9555
Application Number = 72087
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9556
Application Number = 72088
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9557
Application Number = 72089
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9558
Application Number = 72090
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 0.4MG/ML
----
Product id = 9559
Application Number = 72091
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9560
Application Number = 72092
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9561
Application Number = 72093
Date of Application = 11,, Apr, 1989
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = ASTRAZENECA
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 9577
Application Number = 72115
Date of Application = 27,, Apr, 1988
RX/OTC/DISCN = DISCN
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = INTL MEDICATION
ProductNo = 001
Tecode =
Rld = No
Strength = 1MG/ML
----
Product id = 25182
Application Number = 74736
Date of Application = 21,, Jan, 1997
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
Route/format = ORAL / TABLET
Application Type = A
Applicant Name = WATSON LABS
ProductNo = 001
Tecode = AB
Rld = Yes
Strength = EQ 0.5MG BASE;EQ 50MG BASE
----
Product id = 25181
Application Number = 75523
Date of Application = 17,, Mar, 2000
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
Route/format = ORAL / TABLET
Application Type = A
Applicant Name = RANBAXY
ProductNo = 001
Tecode = AB
Rld = No
Strength = EQ 0.5MG BASE;EQ 50MG BASE
----
Product id = 25180
Application Number = 75735
Date of Application = 11,, Jul, 2001
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
Route/format = ORAL / TABLET
Application Type = A
Applicant Name = GAVIS PHARMS
ProductNo = 001
Tecode = AB
Rld = No
Strength = EQ 0.5MG BASE;EQ 50MG BASE
----
Product id = 30160
Application Number = 91149
Date of Application = 8,, Sep, 2014
RX/OTC/DISCN = RX
Tradename = BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Route/format = SUBLINGUAL / TABLET
Application Type = A
Applicant Name = TEVA PHARMS USA
ProductNo = 001
Tecode = AB
Rld = No
Strength = EQ 2MG BASE;EQ 0.5MG BASE
----
Product id = 30161
Application Number = 91149
Date of Application = 8,, Sep, 2014
RX/OTC/DISCN = RX
Tradename = BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Route/format = SUBLINGUAL / TABLET
Application Type = A
Applicant Name = TEVA PHARMS USA
ProductNo = 002
Tecode = AB
Rld = No
Strength = EQ 8MG BASE;EQ 2MG BASE
----
Product id = 30155
Application Number = 91422
Date of Application = 22,, Feb, 2013
RX/OTC/DISCN = RX
Tradename = BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Route/format = SUBLINGUAL / TABLET
Application Type = A
Applicant Name = ACTAVIS ELIZABETH
ProductNo = 001
Tecode = AB
Rld = No
Strength = EQ 2MG BASE;EQ 0.5MG BASE
----
Product id = 30156
Application Number = 91422
Date of Application = 22,, Feb, 2013
RX/OTC/DISCN = RX
Tradename = BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Route/format = SUBLINGUAL / TABLET
Application Type = A
Applicant Name = ACTAVIS ELIZABETH
ProductNo = 002
Tecode = AB
Rld = Yes
Strength = EQ 8MG BASE;EQ 2MG BASE
----
Product id = 30162
Application Number = 203136
Date of Application = 22,, Feb, 2013
RX/OTC/DISCN = RX
Tradename = BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Route/format = SUBLINGUAL / TABLET
Application Type = A
Applicant Name = AMNEAL PHARMS
ProductNo = 001
Tecode = AB
Rld = No
Strength = EQ 2MG BASE;EQ 0.5MG BASE
----
Product id = 30157
Application Number = 203136
Date of Application = 22,, Feb, 2013
RX/OTC/DISCN = RX
Tradename = BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Route/format = SUBLINGUAL / TABLET
Application Type = A
Applicant Name = AMNEAL PHARMS
ProductNo = 002
Tecode = AB
Rld = No
Strength = EQ 8MG BASE;EQ 2MG BASE
----
Product id = 30158
Application Number = 203326
Date of Application = 27,, Jun, 2014
RX/OTC/DISCN = RX
Tradename = BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Route/format = SUBLINGUAL / TABLET
Application Type = A
Applicant Name = ROXANE
ProductNo = 001
Tecode = AB
Rld = No
Strength = EQ 2MG BASE;EQ 0.5MG BASE
----
Product id = 30159
Application Number = 203326
Date of Application = 27,, Jun, 2014
RX/OTC/DISCN = RX
Tradename = BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Route/format = SUBLINGUAL / TABLET
Application Type = A
Applicant Name = ROXANE
ProductNo = 002
Tecode = AB
Rld = No
Strength = EQ 8MG BASE;EQ 2MG BASE
----
Product id = 30218
Application Number = 204242
Date of Application = 3,, Jul, 2013
RX/OTC/DISCN = RX
Tradename = ZUBSOLV
Route/format = SUBLINGUAL / TABLET
Application Type = N
Applicant Name = OREXO AB
ProductNo = 001
Tecode =
Rld = No
Strength = EQ 1.4MG BASE;EQ 0.36MG BASE
----
Product id = 30219
Application Number = 204242
Date of Application = 3,, Jul, 2013
RX/OTC/DISCN = RX
Tradename = ZUBSOLV
Route/format = SUBLINGUAL / TABLET
Application Type = N
Applicant Name = OREXO AB
ProductNo = 002
Tecode =
Rld = Yes
Strength = EQ 5.7MG BASE;EQ 1.4MG BASE
----
Product id = 30220
Application Number = 204242
Date of Application = 11,, Dec, 2014
RX/OTC/DISCN = RX
Tradename = ZUBSOLV
Route/format = SUBLINGUAL / TABLET
Application Type = N
Applicant Name = OREXO AB
ProductNo = 003
Tecode =
Rld = No
Strength = EQ 8.6MG BASE;EQ 2.1MG BASE
----
Product id = 30221
Application Number = 204242
Date of Application = 11,, Dec, 2014
RX/OTC/DISCN = RX
Tradename = ZUBSOLV
Route/format = SUBLINGUAL / TABLET
Application Type = N
Applicant Name = OREXO AB
ProductNo = 004
Tecode =
Rld = No
Strength = EQ 11.4MG BASE;EQ 2.9MG BASE
----
Product id = 9579
Application Number = 204997
Date of Application = 6,, Mar, 2014
RX/OTC/DISCN = RX
Tradename = NALOXONE HYDROCHLORIDE
Route/format = INJECTION / INJECTABLE
Application Type = A
Applicant Name = MYLAN INSTITUTIONAL
ProductNo = 001
Tecode = AP
Rld = No
Strength = 0.4MG/ML
----
Product id = 4790
Application Number = 205637
Date of Application = 6,, Jun, 2014
RX/OTC/DISCN = RX
Tradename = BUNAVAIL
Route/format = BUCCAL / FILM
Application Type = N
Applicant Name = BIODELIVERY SCI INTL
ProductNo = 001
Tecode =
Rld = No
Strength = EQ 2.1MG BASE;EQ 0.3MG BASE
----
Product id = 4791
Application Number = 205637
Date of Application = 6,, Jun, 2014
RX/OTC/DISCN = RX
Tradename = BUNAVAIL
Route/format = BUCCAL / FILM
Application Type = N
Applicant Name = BIODELIVERY SCI INTL
ProductNo = 002
Tecode =
Rld = No
Strength = EQ 4.2MG BASE;EQ 0.7MG BASE
----
Product id = 4792
Application Number = 205637
Date of Application = 6,, Jun, 2014
RX/OTC/DISCN = RX
Tradename = BUNAVAIL
Route/format = BUCCAL / FILM
Application Type = N
Applicant Name = BIODELIVERY SCI INTL
ProductNo = 003
Tecode =
Rld = Yes
Strength = EQ 6.3MG BASE;EQ 1MG BASE
----
Product id = 16655
Application Number = 205777
Date of Application = 23,, Jul, 2014
RX/OTC/DISCN = DISCN
Tradename = TARGINIQ
Route/format = ORAL / TABLET, EXTENDED RELEASE
Application Type = N
Applicant Name = PURDUE PHARMA LP
ProductNo = 001
Tecode =
Rld = No
Strength = 5MG;10MG
----
Product id = 16656
Application Number = 205777
Date of Application = 23,, Jul, 2014
RX/OTC/DISCN = DISCN
Tradename = TARGINIQ
Route/format = ORAL / TABLET, EXTENDED RELEASE
Application Type = N
Applicant Name = PURDUE PHARMA LP
ProductNo = 002
Tecode =
Rld = No
Strength = 10MG;20MG
----
Product id = 16657
Application Number = 205777
Date of Application = 23,, Jul, 2014
RX/OTC/DISCN = DISCN
Tradename = TARGINIQ
Route/format = ORAL / TABLET, EXTENDED RELEASE
Application Type = N
Applicant Name = PURDUE PHARMA LP
ProductNo = 003
Tecode =
Rld = No
Strength = 20MG;40MG
----
Product id = 13467
Application Number = 205787
Date of Application = 3,, Apr, 2014
RX/OTC/DISCN = RX
Tradename = EVZIO
Route/format = INTRAMUSCULAR, SUBCUTANEOUS / SOLUTION
Application Type = N
Applicant Name = KALEO INC
ProductNo = 001
Tecode =
Rld = Yes
Strength = 0.4MG/0.4ML
----