Application 080936

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISONIAZID	ISONIAZID	TABLET;ORAL	100MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A080936-001	ISONIAZID	ISONIAZID	100MG	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 · 44 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
2022-10-28 04:53 UTC	2022-10	A080936-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080936-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080936-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080936-001	ISONIAZID	100MG	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	A080936-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080936-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080936-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080936-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080936-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080936-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080936-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080936-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080936-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080936-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080936-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080936-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080936-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080936-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080936-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080936-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080936-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080936-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080936-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080936-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080936-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080936-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080936-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080936-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080936-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080936-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080936-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080936-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080936-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080936-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080936-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080936-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080936-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080936-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080936-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080936-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080936-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080936-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isoniazid	ISONIAZID	Bryant Ranch Prepack	03bf3bd5-64f9-4491-89fd-96c5c10d0129	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080936 application number: ANDA080936
Isoniazid	ISONIAZID	Genus Lifesciences	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080936 application number: ANDA080936
Isoniazid	ISONIAZID	A-S Medication Solutions	8a309582-1bb7-4b21-af43-c38710ac83d5	2023-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080936 application number: ANDA080936 ndc (product): 50090-0410
Isoniazid	ISONIAZID	Teva Pharmaceuticals USA, Inc.	9499f1cf-2f46-4047-8b71-90aee7dee854	2021-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080936 application number: ANDA080936 ndc (product): 0555-0066

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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0066	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0066	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0066	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0066	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0066	Isoniazid	Isoniazid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-0410	Isoniazid	Isoniazid	A-S Medication Solutions	ANDA	Current
50090-0410	Isoniazid	Isoniazid	A-S Medication Solutions	ANDA	Current
50090-0410	Isoniazid	Isoniazid	A-S Medication Solutions	ANDA	Current
55695-027	Isoniazid	Isoniazid	Department of State Health Services, Pharmacy Branch	ANDA	Current
63629-3707	Isoniazid	Isoniazid	Bryant Ranch Prepack	ANDA	Current
63629-3707	Isoniazid	Isoniazid	Bryant Ranch Prepack	ANDA	Current
70518-0096	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-0096	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-0096	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-0096	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-0096	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-0096	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-0096	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current
70518-0096	Isoniazid	Isoniazid	REMEDYREPACK INC.	ANDA	Current