Application 021108

Type: NDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RENOVA	TRETINOIN	CREAM;TOPICAL	0.02%	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
N021108-001	RENOVA	TRETINOIN	0.02%	CREAM / TOPICAL		RLD, RS	2000-08-31

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 · 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	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021108-001	6531141	2020-03-07	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021108-001	6531141	2020-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021108-001	6531141	2020-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021108-001	6531141	2020-03-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021108-001	6531141	2020-03-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021108-001	6531141	2020-03-07	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Renova	TRETINOIN	Bausch Health US LLC	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021108 application number: NDA021108 ndc (product): 0187-5150

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-5150	Renova	Tretinoin	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5150	Renova	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5150	Renova	Tretinoin	Bausch Health Americas Inc.	NDA	Current
0187-5150	Renova	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5150	Renova	Tretinoin	Bausch Health US LLC	NDA	Current
42254-165	Renova	Tretinoin	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
36123	SUPPL	2014-06-17
4344	SUPPL	2014-06-17
14396	SUPPL	2004-06-15
41954	ORIG	2004-03-28
4343	SUPPL	2002-07-14
14395	ORIG	2000-08-31
4342	ORIG	2000-08-31