Application 008420

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIMIFON	ISONIAZID	SYRUP;ORAL	50MG/5ML	No	No
002	RIMIFON	ISONIAZID	INJECTABLE;INJECTION	25MG/ML	No	No
003	RIMIFON	ISONIAZID	INJECTABLE;INJECTION	100MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N008420-001	RIMIFON	ISONIAZID	50MG/5ML	SYRUP / ORAL	Approved before 1982
N008420-002	RIMIFON	ISONIAZID	25MG/ML	INJECTABLE / INJECTION	Approved before 1982
N008420-003	RIMIFON	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N008420-003	RIMIFON	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008420-001	RIMIFON	50MG/5ML	SYRUP / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N008420-002	RIMIFON	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`

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.	6dab7b7b-a3a9-47ef-b423-134bc6970d8b	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
isoniazid	ISONIAZID	REMEDYREPACK INC.	93252cc8-c8d4-401b-bde5-ca8a3b57651e	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Bryant Ranch Prepack	03bf3bd5-64f9-4491-89fd-96c5c10d0129	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Chartwell RX, LLC	8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
isoniazid	ISONIAZID	Coupler LLC	44592c5c-d11c-148d-e063-6294a90ab35c	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Bryant Ranch Prepack	b6d6dccc-2577-4bbb-896e-5f75b65ee6ca	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
isoniazid	ISONIAZID	A-S Medication Solutions	ed780e28-a2c3-44dc-898a-d2cbe05eeedf	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
isoniazid	ISONIAZID	Marlex Pharmaceuticals, Inc.	312cd403-b211-64ef-e063-6394a90aab88	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Bryant Ranch Prepack	9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
isoniazid	ISONIAZID	OMNIVIUM PHARMACEUTICALS LLC.	35400f1d-fd25-4bfa-a382-ac390e21bf2e	2025-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Coupler LLC	38f4c4af-81da-9b0c-e063-6294a90a8b9d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Genus Lifesciences	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	A-S Medication Solutions	d5039796-6ba0-4fa8-84f7-e47c63d45163	2025-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Sandoz Inc	77795c31-1cdf-4a20-b4a1-cd15f5b310f1	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Chartwell RX, LLC	2e09b1a5-9786-427f-bf00-be15b06eb7e7	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
isoniazid	ISONIAZID	Bryant Ranch Prepack	eeaf09a3-5631-4089-9f17-15750c002e32	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
isoniazid	ISONIAZID	Bryant Ranch Prepack	63bf1fe0-5d74-4123-88b7-a95d521befca	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	Mylan Institutional Inc.	60a6b514-fa7f-4bc7-85b0-e5a14fa56b59	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	CMP Pharma, Inc.	db8a3ae7-fb5b-47a9-a9f7-f57cd90501c2	2024-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID
Isoniazid	ISONIAZID	A-S Medication Solutions	8a309582-1bb7-4b21-af43-c38710ac83d5	2023-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ISONIAZID

Reported adverse events (FAERS/openFDA)#

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