Application 040090

Type: ANDA
Sponsor: ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISONIAZID	ISONIAZID	TABLET;ORAL	100MG	No	No
002	ISONIAZID	ISONIAZID	TABLET;ORAL	300MG	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
A040090-001	ISONIAZID	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26
A040090-002	ISONIAZID	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040090-001	AA
A040090-002	AA

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	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`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	A040090-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040090-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040090-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040090-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040090-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040090-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040090-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040090-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040090-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040090-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040090-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040090-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040090-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040090-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040090-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040090-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040090-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040090-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040090-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040090-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040090-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040090-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040090-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040090-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040090-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040090-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040090-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040090-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040090-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040090-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040090-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040090-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040090-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040090-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040090-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040090-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040090-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040090-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040090-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040090-002	AA	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
isoniazid	ISONIAZID	REMEDYREPACK INC.	93252cc8-c8d4-401b-bde5-ca8a3b57651e	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	Coupler LLC	44592c5c-d11c-148d-e063-6294a90ab35c	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	A-S Medication Solutions	ed780e28-a2c3-44dc-898a-d2cbe05eeedf	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	Marlex Pharmaceuticals, Inc.	312cd403-b211-64ef-e063-6394a90aab88	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	OMNIVIUM PHARMACEUTICALS LLC.	35400f1d-fd25-4bfa-a382-ac390e21bf2e	2025-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	Bryant Ranch Prepack	eeaf09a3-5631-4089-9f17-15750c002e32	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	Bryant Ranch Prepack	63bf1fe0-5d74-4123-88b7-a95d521befca	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46672-865	isoniazid	isoniazid	Mikart, LLC	ANDA	Current
46672-865	isoniazid	isoniazid	Mikart, Inc.	ANDA	Current
46672-866	isoniazid	isoniazid	Mikart, LLC	ANDA	Current
46672-866	isoniazid	isoniazid	Mikart, Inc.	ANDA	Current