Application 078633

Type: ANDA
Sponsor: HIKMA

Application Products#

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

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
A078633-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08
A078633-002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078633-001	AB
A078633-002	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	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078633-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2009-10-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078633-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	RS	2009-10-08	`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	A078633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078633-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078633-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078633-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078633-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078633-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078633-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078633-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078633-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078633-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078633-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078633-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078633-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078633-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078633-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078633-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078633-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078633-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078633-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078633-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078633-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078633-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078633-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078633-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078633-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078633-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078633-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078633-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078633-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078633-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078633-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078633-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078633-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078633-002	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine HCl	BUPRENORPHINE HCL	REMEDYREPACK INC.	e1aac2bb-cb83-46cb-9a29-502a62010667	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633 ndc (product): 70518-2226
Buprenorphine	BUPRENORPHINE	Major Pharmaceuticals	dba586f9-e3f2-4b9c-849b-907c81a5a0ef	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633 ndc (product): 0904-7155 ndc (product): 0904-7154
Buprenorphine HCl	BUPRENORPHINE HCL	REMEDYREPACK INC.	69a647c0-bc09-4ee2-aeb3-ef286caf25e5	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633 ndc (product): 70518-2014
Buprenorphine	BUPRENORPHINE	Hikma Pharmaceuticals USA Inc.	1bf8b35a-b769-465c-a2f8-099868dfcd2f	2026-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633 ndc (product): 0054-0176 ndc (product): 0054-0177
Buprenorphine HCl	BUPRENORPHINE HCL	Redpharm Drug	301eaed5-8499-ad95-e063-6294a90a58f5	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine HCl	BUPRENORPHINE HCL	Bryant Ranch Prepack	d5a8c41e-413e-4d48-9739-d158e5681dd0	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633 ndc (product): 71335-1163
Buprenorphine Sublingual C-III	BUPRENORPHINE SUBLINGUAL C-III	Direct_Rx	22412030-a641-28d8-e063-6294a90a2fef	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine Sublingual C-III	BUPRENORPHINE SUBLINGUAL C-III	Direct_Rx	248524c6-4c8b-a450-e063-6394a90a81ef	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633
Buprenorphine HCl	BUPRENORPHINE HCL	Clinical Solutions Wholesale, LLC	3a7418a2-bd6e-4082-b0fe-a5498e7b944a	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078633 application number: ANDA078633 ndc (product): 58118-0177 ndc (product): 58118-0176

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0904-7154	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7154	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7154	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7155	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7155	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7155	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
55700-302	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-302	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-302	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-303	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-303	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58118-0176	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0176	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0176	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0177	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0177	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0177	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
67046-998	Buprenorphine HCl	Buprenorphine HCl	Contract Pharmacy Services-PA	ANDA	Current
67046-999	Buprenorphine HCl	Buprenorphine HCl	Contract Pharmacy Services-PA	ANDA	Current
70518-2014	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2014	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2014	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2014	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2226	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2226	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2226	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
71335-1163	Buprenorphine HCl	Buprenorphine HCl	Bryant Ranch Prepack	ANDA	Current
71335-1163	Buprenorphine HCl	Buprenorphine HCl	Bryant Ranch Prepack	ANDA	Current
71335-1163	Buprenorphine HCl	Buprenorphine HCl	Bryant Ranch Prepack	ANDA	Current
71335-1163	Buprenorphine HCl	Buprenorphine HCl	Bryant Ranch Prepack	ANDA	Current
76519-1170	BUPRENORPHINE HCL	BUPRENORPHINE HCL	H.J. Harkins Company, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44539	ORIG	2015-07-02
31378	ORIG	2009-10-14