Application 050705

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIFATER	ISONIAZID; PYRAZINAMIDE; RIFAMPIN	TABLET;ORAL	50MG;300MG;120MG	Yes	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
N050705-001	RIFATER	ISONIAZID; PYRAZINAMIDE; RIFAMPIN	50MG;300MG;120MG	TABLET / ORAL		RLD	1994-05-31

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD, RS	1994-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD, RS	1994-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD, RS	1994-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD, RS	1994-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD, RS	1994-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050705-001	RIFATER	50MG;300MG;120MG	TABLET / ORAL	RLD	1994-05-31	`f41ea6bd6efb…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0088-0576	Rifater	rifampin, isoniazid and pyrazinamide	sanofi-aventis U.S. LLC	NDA	Current
0088-0576	Rifater	rifampin, isoniazid and pyrazinamide	sanofi-aventis U.S. LLC	NDA	Current
0088-0576	Rifater	rifampin, isoniazid and pyrazinamide	sanofi-aventis U.S. LLC	NDA	Current
0088-0576	Rifater	rifampin, isoniazid and pyrazinamide	sanofi-aventis U.S. LLC	NDA	Current
0088-0576	Rifater	rifampin, isoniazid and pyrazinamide	sanofi-aventis U.S. LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84406	SUPPL	2025-12-15
84369	SUPPL	2025-12-09
83705	SUPPL	2025-10-09
83698	SUPPL	2025-10-09
81122	SUPPL	2025-02-07
81076	SUPPL	2025-02-06
79871	SUPPL	2024-10-11
79866	SUPPL	2024-10-11
76768	SUPPL	2023-12-12
76756	SUPPL	2023-12-11
75125	SUPPL	2023-08-18
75100	SUPPL	2023-08-17
73498	SUPPL	2023-02-14
73460	SUPPL	2023-02-13
70048	SUPPL	2022-02-02
69997	SUPPL	2022-01-31
69086	SUPPL	2021-10-25
69083	SUPPL	2021-10-25
67874	SUPPL	2021-06-23
67865	SUPPL	2021-06-22
62959	SUPPL	2020-05-13
62948	SUPPL	2020-05-13
59862	SUPPL	2019-08-28
59860	SUPPL	2019-08-28
57930	SUPPL	2019-03-07
57862	SUPPL	2019-03-01
57529	SUPPL	2019-02-13
57344	SUPPL	2019-01-25
51012	SUPPL	2018-01-10
51002	SUPPL	2018-01-09
48139	SUPPL	2017-04-27
48098	SUPPL	2017-04-25
39137	SUPPL	2013-03-01
8038	SUPPL	2013-03-01
8037	SUPPL	2010-11-22
39136	SUPPL	2010-11-17
18044	SUPPL	2009-01-02
30303	SUPPL	2008-12-29
18043	SUPPL	2005-05-02
8036	SUPPL	2005-05-02