Application 203326

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 2MG BASE;EQ 0.5MG BASE	No	No
002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 8MG BASE;EQ 2MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27
A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203326-001	AB
A203326-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	RS	2014-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203326-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203326-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2014-06-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203326-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203326-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203326-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203326-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203326-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203326-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203326-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203326-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203326-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203326-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203326-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203326-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203326-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203326-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203326-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203326-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203326-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203326-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203326-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203326-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203326-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203326-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203326-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203326-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203326-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203326-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203326-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203326-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203326-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203326-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203326-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203326-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203326-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203326-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203326-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203326-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203326-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203326-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203326-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203326-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
buprenorphine and naloxone	BUPRENORPHINE AND NALOXONE	Hikma Pharmaceuticals USA Inc.	713db2c6-0544-4633-b874-cfbeaf93db89	2026-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203326 application number: ANDA203326 ndc (product): 0054-0188 ndc (product): 0054-0189
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	REMEDYREPACK INC.	43027750-d218-49e5-867f-c941736d2056	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203326 application number: ANDA203326
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	REMEDYREPACK INC.	4124c4ad-ef62-4c95-8e57-0d843862ae71	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203326 application number: ANDA203326
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Bryant Ranch Prepack	a0f8c28c-ed9a-4a26-91a3-b996c117ac2c	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203326 application number: ANDA203326 ndc (product): 71335-1720
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Bryant Ranch Prepack	d25b1a73-9794-4e86-82eb-dee3f159a214	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203326 application number: ANDA203326 ndc (product): 71335-1653
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Golden State Medical Supply, Inc.	4f6e0056-b19d-0d0e-e063-6294a90a16e5	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203326 application number: ANDA203326
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Clinical Solutions Wholesale, LLC	99a5b62f-bc08-44f4-abb8-300520d2162a	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203326 application number: ANDA203326
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE	Major Pharmaceuticals	c5fbec69-e7de-44a8-b9fa-0378ae61a9fe	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203326 application number: ANDA203326 ndc (product): 0904-7010 ndc (product): 0904-7009

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0904-7009	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Major Pharmaceuticals	ANDA	Current
0904-7009	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Major Pharmaceuticals	ANDA	Current
0904-7010	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Major Pharmaceuticals	ANDA	Current
0904-7010	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Major Pharmaceuticals	ANDA	Current
0904-7010	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Major Pharmaceuticals	ANDA	Current
71335-1653	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Bryant Ranch Prepack	ANDA	Current
71335-1653	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Bryant Ranch Prepack	ANDA	Current
71335-1653	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Bryant Ranch Prepack	ANDA	Current
71335-1720	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Bryant Ranch Prepack	ANDA	Current
71335-1720	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Bryant Ranch Prepack	ANDA	Current
71335-1720	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44588	ORIG	2015-07-02