Application 080937

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ISONIAZID	ISONIAZID	TABLET;ORAL	300MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080937-002	ISONIAZID	ISONIAZID	300MG	TABLET / ORAL		Approved before 1982

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080937-002	ISONIAZID	300MG	TABLET / ORAL		Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A080937-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080937-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080937-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080937-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080937-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080937-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080937-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080937-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080937-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080937-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080937-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080937-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080937-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080937-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080937-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080937-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080937-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080937-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080937-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080937-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080937-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080937-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080937-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080937-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080937-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080937-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080937-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080937-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080937-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080937-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080937-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080937-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080937-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080937-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080937-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080937-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080937-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080937-002	AA	1	`cb3db0bc1861…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isoniazid	ISONIAZID	REMEDYREPACK INC.	6dab7b7b-a3a9-47ef-b423-134bc6970d8b	2026-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Bryant Ranch Prepack	b6d6dccc-2577-4bbb-896e-5f75b65ee6ca	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Bryant Ranch Prepack	9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Coupler LLC	38f4c4af-81da-9b0c-e063-6294a90a8b9d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Genus Lifesciences	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	A-S Medication Solutions	d5039796-6ba0-4fa8-84f7-e47c63d45163	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937 ndc (product): 50090-0370
Isoniazid	ISONIAZID	Mylan Institutional Inc.	60a6b514-fa7f-4bc7-85b0-e5a14fa56b59	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937 ndc (product): 51079-083
Isoniazid	ISONIAZID	Teva Pharmaceuticals USA, Inc.	9499f1cf-2f46-4047-8b71-90aee7dee854	2021-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937 ndc (product): 0555-0071
Isoniazid	ISONIAZID	Aphena Pharma Solutions - Tennessee, LLC	cb6f5638-2d3a-4334-b272-6b4772d32d03	2020-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937 ndc (product): 71610-395
Isoniazid	ISONIAZID	Proficient Rx LP	65e50989-d24c-4bb3-a041-d6aea2635ef1	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937 ndc (product): 63187-978

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-1655	Isoniazid	Isoniazid	Liberty Pharmaceuticals, Inc.	ANDA	Current
0555-0071	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0071	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0071	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0071	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0071	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
43063-463	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-463	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-463	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-463	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-463	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-463	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0370	Isoniazid	Isoniazid	A-S Medication Solutions	ANDA	Current
50090-0370	Isoniazid	Isoniazid	A-S Medication Solutions	ANDA	Current
51079-083	Isoniazid	Isoniazid	Mylan Institutional Inc.	ANDA	Current
51079-083	Isoniazid	Isoniazid	Mylan Institutional Inc.	ANDA	Current
51079-083	Isoniazid	Isoniazid	Mylan Institutional Inc.	ANDA	Current
51079-083	Isoniazid	Isoniazid	Mylan Institutional Inc.	ANDA	Current
51655-391	Isoniazid	Isoniazid	Northwind Pharmaceuticals, LLC	ANDA	Current
53002-2920	Isoniazid	Isoniazid	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2920	Isoniazid	Isoniazid	RPK Pharmaceuticals, Inc.	ANDA	Current
53808-1041	Isoniazid	Isoniazid	State of Florida DOH Central Pharmacy	ANDA	Current
55695-033	Isoniazid	Isoniazid	Department of State Health Services, Pharmacy Branch	ANDA	Current
60687-553	Isoniazid	Isoniazid	American Health Packaging	ANDA	Current
60687-553	Isoniazid	Isoniazid	American Health Packaging	ANDA	Current
63187-978	Isoniazid	Isoniazid	Proficient Rx LP	ANDA	Current
63187-978	Isoniazid	Isoniazid	Proficient Rx LP	ANDA	Current
66267-124	Isoniazid	Isoniazid	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-124	Isoniazid	Isoniazid	NuCare Pharmaceuticals, Inc.	ANDA	Current
67046-333	Isoniazid	Isoniazid	Contract Pharmacy Services-PA	ANDA	Current
68788-9405	Isoniazid	Isoniazid	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9405	Isoniazid	Isoniazid	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9405	Isoniazid	Isoniazid	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9405	Isoniazid	Isoniazid	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9405	Isoniazid	Isoniazid	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0595	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-0595	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-1491	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-1491	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-2576	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-2576	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-2576	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-2576	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70934-642	Isoniazid	Isoniazid	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-0275	Isoniazid	Isoniazid	Bryant Ranch Prepack	ANDA	Current
71335-0275	Isoniazid	Isoniazid	Bryant Ranch Prepack	ANDA	Current
71610-395	Isoniazid	Isoniazid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current