Application 016921

Type: NDA
Sponsor: VALEANT INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETIN-A	TRETINOIN	SOLUTION;TOPICAL	0.05%	Yes	No
002	RETIN-A	TRETINOIN	SWAB;TOPICAL	0.05%	No	No

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

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
N016921-001	RETIN-A	TRETINOIN	0.05%	SOLUTION / TOPICAL		RLD, Approved before 1982
N016921-002	RETIN-A	TRETINOIN	0.05%	SWAB / TOPICAL		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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016921-001	RETIN-A	0.05%	SOLUTION / TOPICAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016921-002	RETIN-A	0.05%	SWAB / TOPICAL	Approved before 1982	`782e0a99824c…`

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Redpharm Drug	57d1e8ed-ffc8-5e19-e063-6294a90af941	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Limited	5304df69-5d29-48f5-8227-80c7a6f12e6d	2026-07-01	Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Inc.	49e542a3-57cc-482f-9118-4174c80742dd	2026-06-26	Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Major Pharmaceuticals	045258e2-5efb-4147-bf74-4c43af04dccc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Amneal Pharmaceuticals NY LLC	4b6006e3-f7a4-4823-8217-3e5b0f7e58d9	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
TRETINOIN	TRETINOIN	Encube Ethicals, Inc.	57558405-42fa-40bb-a61c-48e030d976de	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
TRETINOIN	TRETINOIN	REMEDYREPACK INC.	c4d5155b-046d-4f94-bafc-651b572c2bd5	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Encube Ethicals, Inc.	5e3fb8ea-234c-4be2-95a7-d139e069cf98	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Par Health USA, LLC	9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Bryant Ranch Prepack	2b58cf56-e713-4cdd-8b4e-e6651ef76650	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Renova	TRETINOIN	Bausch Health US LLC	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	A-S Medication Solutions	44be2556-1ea9-49e9-86dd-991fbcc6348d	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Glenmark Pharmaceuticals Inc., USA	264138c1-9e5f-45ef-be87-79ca97c989d9	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
TRETINOIN	TRETINOIN	Preferred Pharmaceuticals Inc.	d6819051-4748-479e-8b53-c298edcbd410	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Inc.	872b3f8f-c073-4808-a106-840188ac7a00	2026-01-23	Adverse reactions	Name fallback generic name: TRETINOIN
TRETINOIN	TRETINOIN	NuCare Pharmaceuticals,Inc.	47fc341b-8cff-9d63-e063-6394a90abdfd	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	American Health Packaging	b22d5a07-623a-4645-b87d-a151b86da8d5	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Bryant Ranch Prepack	04f14d6e-5b44-44bd-a7f3-d684d9c5d7cb	2025-10-21	Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Bryant Ranch Prepack	a1ae0000-3411-47e5-94f2-ae2ee70eadfb	2025-10-21	Adverse reactions	Name fallback generic name: TRETINOIN
TRETINOIN	TRETINOIN	Bryant Ranch Prepack	8929196c-389a-4c43-843c-00fbb26a1dd9	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33207	SUPPL	2002-06-10
13053	SUPPL	2002-06-10
13052	SUPPL	2002-06-10
10936	SUPPL	2002-06-10
10935	SUPPL	2002-06-10
516	SUPPL	2002-06-10