Application 050420

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIFADIN	RIFAMPIN	CAPSULE;ORAL	300MG	Yes	Yes
002	RIFADIN	RIFAMPIN	CAPSULE;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No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
N050420-001	RIFADIN	RIFAMPIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982
N050420-002	RIFADIN	RIFAMPIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982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 2 · 47 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
2026-08-18 06:07:40	2026-07	N050420-001	RIFADIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050420-002	RIFADIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050420-001	RIFADIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050420-002	RIFADIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050420-001	RIFADIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050420-002	RIFADIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050420-002	RIFADIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050420-001	RIFADIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050420-001	RIFADIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050420-001	RIFADIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050420-001	RIFADIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050420-001	RIFADIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050420-001	RIFADIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050420-001	RIFADIN	300MG	CAPSULE / ORAL		RLD, Approved before 1982	`053a50430f4f…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050420-001	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N050420-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050420-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050420-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050420-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050420-001	AB	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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rifadin	RIFAMPICIN	Sanofi-Aventis U.S. LLC	1b074c23-dd35-43c9-820c-0e603481fdd3	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Rifadin
Rifadin IV	RIFAMPIN	Sanofi-Aventis U.S. LLC	036ab68e-5085-4edc-bd83-784b43d64eab	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
Rifampin	RIFAMPIN	Mylan Institutional LLC	8be91604-d7cd-4f2b-997d-e3364e4092e5	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
rifampin	RIFAMPIN	Bryant Ranch Prepack	0cb75e95-d165-4580-9340-42d7a9fd546e	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
rifampin	RIFAMPIN	Major Pharmaceuticals	3f3534c1-95e4-4bdd-b044-9026e4addf0c	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
rifampin	RIFAMPIN	Lupin Pharmaceuticals, Inc.	b56004f0-f23d-47f6-80c7-39884fccbccc	2026-02-11	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
rifampin	RIFAMPIN	A-S Medication Solutions	d53b6998-6e3b-4c6f-8465-2af6897d1efe	2026-01-05	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
RIFAMPIN	RIFAMPIN	Coupler LLC	410a314f-83bf-d9b3-e063-6294a90a872c	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
Rifampin	RIFAMPIN	American Health Packaging	50f706f9-5003-4e15-bece-85b6213b1f5c	2025-08-20	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
RIFAMPIN	RIFAMPIN	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	28109dee-3e5e-492b-b7d9-9ba46c0b5324	2025-03-25	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
Rifampin	RIFAMPIN	ANI Pharmaceuticals, Inc.	b389b1a3-672f-47e3-916c-4a9c044b211b	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
RIFAMPIN	RIFAMPIN	EPIC PHARMA, LLC	0391f1e1-70d4-4b15-8b58-055bb6a385b8	2023-12-20	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
Rifampin	RIFAMPIN	Chartwell RX, LLC	4c39ee75-ae96-456d-bf47-16d49865345e	2023-04-12	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
Rifampin	RIFAMPIN	Fresenius Kabi USA, LLC	a1f9f1e2-dfc0-4d31-a13b-b656d897b791	2022-08-29	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN
Rifampin	RIFAMPIN	Hikma Pharmaceuticals USA Inc.	cb59a48c-f66b-4ea0-809c-de0e4be2f8c2	2022-01-28	Warnings, Adverse reactions	Name fallback generic name: RIFAMPIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0068-0508	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0508	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0508	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0508	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0508	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0508	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0508	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0508	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0510	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0510	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0510	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0510	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0510	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0510	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0510	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current
0068-0510	Rifadin	rifampin	Sanofi-Aventis U.S. LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84407	SUPPL	2025-12-15
84371	SUPPL	2025-12-09
83706	SUPPL	2025-10-09
83699	SUPPL	2025-10-09
79872	SUPPL	2024-10-11
79863	SUPPL	2024-10-11
76766	SUPPL	2023-12-12
76758	SUPPL	2023-12-11
75121	SUPPL	2023-08-18
75104	SUPPL	2023-08-17
73581	SUPPL	2023-02-21
73572	SUPPL	2023-02-21
73495	SUPPL	2023-02-14
73458	SUPPL	2023-02-13
70049	SUPPL	2022-02-02
70000	SUPPL	2022-01-31
69077	SUPPL	2021-10-22
69066	SUPPL	2021-10-21
67872	SUPPL	2021-06-23
67860	SUPPL	2021-06-22
62952	SUPPL	2020-05-13
62950	SUPPL	2020-05-13
59864	SUPPL	2019-08-28
59858	ORIG	2019-08-28
57928	SUPPL	2019-03-07
57860	SUPPL	2019-03-01
57575	SUPPL	2019-02-13
57345	SUPPL	2019-01-25
51010	SUPPL	2018-01-10
51003	SUPPL	2018-01-09
48140	SUPPL	2017-04-27
48101	SUPPL	2017-04-25
38934	SUPPL	2013-03-01
7734	SUPPL	2013-03-01
30015	SUPPL	2010-11-22
17821	SUPPL	2010-11-12
38933	SUPPL	2004-08-25
30014	SUPPL	2004-08-25