Application 008678

Type: NDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ISONIAZID	ISONIAZID	TABLET;ORAL	100MG	Yes	No
003	ISONIAZID	ISONIAZID	TABLET;ORAL	300MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N008678-002	ISONIAZID	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N008678-003	ISONIAZID	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008678-002	ISONIAZID	100MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008678-003	ISONIAZID	300MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008678-002	ISONIAZID	100MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008678-003	ISONIAZID	300MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008678-002	ISONIAZID	100MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008678-003	ISONIAZID	300MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008678-002	ISONIAZID	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008678-003	ISONIAZID	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N008678-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N008678-003	AA	1	`ea99ee380514…`

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 2 · 23 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	Name fallback brand name: isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Bryant Ranch Prepack	03bf3bd5-64f9-4491-89fd-96c5c10d0129	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	REMEDYREPACK INC.	6dab7b7b-a3a9-47ef-b423-134bc6970d8b	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Chartwell RX, LLC	8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
isoniazid	ISONIAZID	Coupler LLC	44592c5c-d11c-148d-e063-6294a90ab35c	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Bryant Ranch Prepack	b6d6dccc-2577-4bbb-896e-5f75b65ee6ca	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
isoniazid	ISONIAZID	A-S Medication Solutions	ed780e28-a2c3-44dc-898a-d2cbe05eeedf	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: isoniazid generic name: ISONIAZID
isoniazid	ISONIAZID	Marlex Pharmaceuticals, Inc.	312cd403-b211-64ef-e063-6394a90aab88	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Bryant Ranch Prepack	9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
isoniazid	ISONIAZID	OMNIVIUM PHARMACEUTICALS LLC.	35400f1d-fd25-4bfa-a382-ac390e21bf2e	2025-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Coupler LLC	38f4c4af-81da-9b0c-e063-6294a90a8b9d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Genus Lifesciences	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	A-S Medication Solutions	d5039796-6ba0-4fa8-84f7-e47c63d45163	2025-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Sandoz Inc	77795c31-1cdf-4a20-b4a1-cd15f5b310f1	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Chartwell RX, LLC	2e09b1a5-9786-427f-bf00-be15b06eb7e7	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
isoniazid	ISONIAZID	Bryant Ranch Prepack	eeaf09a3-5631-4089-9f17-15750c002e32	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: isoniazid generic name: ISONIAZID
isoniazid	ISONIAZID	Bryant Ranch Prepack	63bf1fe0-5d74-4123-88b7-a95d521befca	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	Mylan Institutional Inc.	60a6b514-fa7f-4bc7-85b0-e5a14fa56b59	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	CMP Pharma, Inc.	db8a3ae7-fb5b-47a9-a9f7-f57cd90501c2	2024-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID
Isoniazid	ISONIAZID	A-S Medication Solutions	8a309582-1bb7-4b21-af43-c38710ac83d5	2023-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Isoniazid generic name: ISONIAZID

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-4350	Isoniazid	Isoniazid	Eon Labs, Inc.	NDA	Current
0185-4351	Isoniazid	Isoniazid	Eon Labs, Inc.	NDA	Current
43063-709	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-710	Isoniazid	Isoniazid	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68788-8927	Isoniazid	Isoniazid	Preferred Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81123	SUPPL	2025-02-07
81110	SUPPL	2025-02-06
10705	SUPPL	2016-07-21
156	SUPPL	2016-07-14
155	SUPPL	2007-05-01
154	SUPPL	2007-05-01