Application 017955

Type: NDA
Sponsor: VALEANT INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETIN-A	TRETINOIN	GEL;TOPICAL	0.01%	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
N017955-001	RETIN-A	TRETINOIN	0.01%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017955-001	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 2 of 2 · 43 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
2022-09-29 23:25 UTC	2022-09	N017955-001	RETIN-A	0.01%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017955-001	RETIN-A	0.01%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017955-001	RETIN-A	0.01%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N017955-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017955-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017955-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017955-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017955-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017955-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017955-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017955-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017955-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017955-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017955-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017955-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017955-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017955-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017955-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017955-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017955-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017955-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017955-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017955-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017955-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017955-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017955-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017955-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017955-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017955-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017955-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017955-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017955-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017955-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017955-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017955-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017955-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017955-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017955-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017955-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017955-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017955-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017955-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017955-001	AB	1	`f41ea6bd6efb…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Bryant Ranch Prepack	04f14d6e-5b44-44bd-a7f3-d684d9c5d7cb	2025-10-21	Adverse reactions	Exact identifier application applno (NDA): 017955 application number: NDA017955
Tretinoin	TRETINOIN	Mylan Pharmaceuticals Inc.	ba377a5e-e48a-4bd9-9d76-929d70793396	2024-10-09	Adverse reactions	Exact identifier application applno (NDA): 017955 application number: NDA017955 ndc (product): 0378-8085
Retin-A	TRETINOIN	Bausch Health US, LLC	9556d73d-c573-4e0a-9feb-764ce2d1107b	2024-05-17	Adverse reactions	Exact identifier application applno (NDA): 017955 application number: NDA017955 ndc (product): 0187-5172

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-5172	Retin-A	Tretinoin	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5172	Retin-A	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5172	Retin-A	Tretinoin	Bausch Health US, LLC	NDA	Current
0187-5172	Retin-A	Tretinoin	Bausch Health Americas Inc.	NDA	Current
0187-5172	Retin-A	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5172	Retin-A	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5172	Retin-A	Tretinoin	Bausch Health US, LLC	NDA	Current
0378-8085	Tretionin	Tretionin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8085	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8085	Tretionin	Tretionin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8085	Tretionin	Tretionin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8085	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8085	Tretionin	Tretionin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8085	Tretionin	Tretionin	Mylan Pharmaceuticals Inc	NDA AUTHORIZED	Current
66530-256	Tretinoin	Tretinoin	Spear Dermatology Products Inc	NDA AUTHORIZED GENERIC	Current
66530-256	Tretinoin	Tretinoin	Spear Dermatology Products Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33374	SUPPL	2002-06-10
13960	SUPPL	2002-06-10
13959	SUPPL	2002-06-10
11096	SUPPL	2002-06-10
11095	SUPPL	2002-06-10
755	SUPPL	2002-06-10