Application 021024

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRIFTIN	RIFAPENTINE	TABLET;ORAL	150MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021024-001	PRIFTIN	RIFAPENTINE	150MG	TABLET / ORAL	AB	RLD, RS	1998-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021024-001	AB

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021024-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Priftin	RIFAPENTINE	sanofi-aventis U.S. LLC	3a64fb70-b85e-43d9-8bcd-7e893f568ae1	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021024 application number: NDA021024 ndc (product): 0088-2102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0088-2100	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2100	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2100	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2100	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2102	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2102	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2102	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2102	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2102	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
0088-2102	Priftin	rifapentine	sanofi-aventis U.S. LLC	NDA	Current
50090-5063	Priftin	rifapentine	A-S Medication Solutions	NDA	Current
50090-5063	Priftin	rifapentine	A-S Medication Solutions	NDA	Current
50090-5063	Priftin	rifapentine	A-S Medication Solutions	NDA	Current
50090-5063	Priftin	rifapentine	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84868	SUPPL	2026-01-28
84867	SUPPL	2026-01-28
84854	SUPPL	2026-01-28
63475	SUPPL	2020-06-10
63445	SUPPL	2020-06-08
63443	SUPPL	2020-06-08
63437	SUPPL	2020-06-08
63436	SUPPL	2020-06-08
63435	SUPPL	2020-06-08
63434	SUPPL	2020-06-08
35917	SUPPL	2015-07-23
4078	SUPPL	2015-07-08
43692	SUPPL	2014-12-11
35916	SUPPL	2014-12-03
4077	SUPPL	2014-11-26
26520	SUPPL	2014-11-24
21357	SUPPL	2013-06-03
4076	SUPPL	2010-08-09
35915	SUPPL	2010-07-30
14193	SUPPL	2009-06-03
4075	SUPPL	2009-06-02
41885	SUPPL	2000-10-20
35914	SUPPL	2000-10-20
26519	SUPPL	2000-10-20
41884	ORIG	1998-06-22
35913	ORIG	1998-06-22
26518	ORIG	1998-06-22
51642	SUPPL	1900-01-01
51641	SUPPL	1900-01-01
51640	SUPPL	1900-01-01