Application 020475

Type: NDA
Sponsor: VALEANT INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETIN-A MICRO	TRETINOIN	GEL;TOPICAL	0.1%	Yes	Yes
002	RETIN-A MICRO	TRETINOIN	GEL;TOPICAL	0.04%	Yes	Yes
003	RETIN-A-MICRO	TRETINOIN	GEL;TOPICAL	0.08%	Yes	Yes
004	RETIN-A-MICRO	TRETINOIN	GEL;TOPICAL	0.06%	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020475-001	RETIN-A MICRO	TRETINOIN	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07
N020475-002	RETIN-A MICRO	TRETINOIN	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10
N020475-003	RETIN-A-MICRO	TRETINOIN	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28
N020475-004	RETIN-A-MICRO	TRETINOIN	0.06%	GEL / TOPICAL	AB	RLD, RS	2017-10-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020475-003	AB
N020475-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020475-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020475-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020475-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020475-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020475-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020475-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020475-003	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N020475-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020475-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020475-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020475-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020475-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020475-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020475-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020475-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020475-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020475-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020475-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020475-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020475-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020475-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020475-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020475-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020475-003	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020475-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020475-004	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Oceanside Pharmaceuticals	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020475 application number: NDA020475 ndc (product): 68682-515 ndc (product): 68682-514 ndc (product): 68682-513
Retin-A MICRO	TRETINOIN	Bausch Health US LLC	08ab7e0c-1437-455f-815c-98904d96a289	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020475 application number: NDA020475 ndc (product): 0187-5146 ndc (product): 0187-5140 ndc (product): 0187-5144 ndc (product): 0187-5148

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-5140	Retin-A MICRO	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5140	Retin-A MICRO	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5140	Retin-A MICRO	Tretinoin	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5140	Retin-A MICRO	Tretinoin	Bausch Health Americas Inc.	NDA	Current
0187-5144	Retin-A MICRO	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5144	Retin-A MICRO	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5144	Retin-A MICRO	Tretinoin	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5144	Retin-A MICRO	Tretinoin	Bausch Health Americas Inc.	NDA	Current
0187-5146	Retin-A MICRO	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5146	Retin-A MICRO	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5146	Retin-A MICRO	Tretinoin	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5146	Retin-A MICRO	Tretinoin	Bausch Health Americas Inc.	NDA	Current
0187-5148	Retin-A MICRO	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5148	Retin-A MICRO	Tretinoin	Bausch Health US LLC	NDA	Current
0187-5148	Retin-A MICRO	Tretinoin	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5148	Retin-A MICRO	Tretinoin	Bausch Health Americas Inc.	NDA	Current
0378-8092	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8092	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8092	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8092	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8092	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8093	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8093	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8093	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8093	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8093	Tretinoin	Tretinoin	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
66530-259	Tretinoin Gel Microsphere	Tretinoin	Spear Dermatology Products Inc	NDA AUTHORIZED GENERIC	Current
66530-260	Tretinoin Gel Microsphere	Tretinoin	Spear Dermatology Products Inc	NDA AUTHORIZED GENERIC	Current
68682-513	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-513	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-513	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-514	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-514	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-514	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-515	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-515	Tretinoin	Tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85992	SUPPL	2026-05-21
85644	SUPPL	2026-04-07
85643	SUPPL	2026-04-07
83320	SUPPL	2025-09-11
41387	SUPPL	2015-08-25
12619	SUPPL	2014-01-31
34688	SUPPL	2002-05-10
2578	SUPPL	2002-05-10
41386	ORIG	1997-02-07