Application 077684

Type: ANDA
Sponsor: BARR LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRETINOIN	TRETINOIN	CAPSULE;ORAL	10MG	No	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
A077684-001	TRETINOIN	TRETINOIN	10MG	CAPSULE / ORAL			2007-06-22

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 · 43 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
2026-09-14 22:38:34	2026-08	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL			2007-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL			2007-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL			2007-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL			2007-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL			2007-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL			2007-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077684-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2007-06-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077684-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077684-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077684-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077684-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077684-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077684-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077684-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077684-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077684-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077684-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077684-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077684-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077684-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077684-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077684-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077684-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077684-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077684-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077684-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077684-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077684-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077684-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077684-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077684-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077684-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077684-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077684-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077684-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077684-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077684-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077684-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077684-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077684-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077684-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077684-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077684-001	AB	1	`cb3db0bc1861…`

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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin Cream	TRETINOIN	Obagi Cosmeceuticals LLC	745cc3ce-60b4-4479-a055-316817567949	2025-02-11	Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Actavis Pharma, Inc.	b5e385a2-f6f9-41cb-8a33-eedba397043f	2024-12-11	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin (Microsphere)	TRETINOIN	Mayne Pharma	ed2103ee-c9d5-4b3d-b525-318cf67be050	2024-10-28	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Mylan Pharmaceuticals Inc.	ba377a5e-e48a-4bd9-9d76-929d70793396	2024-10-09	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Bryant Ranch Prepack	7a7974c7-8b6c-41ae-9a48-a08a1439087a	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	A-S Medication Solutions	06ebaf8e-3648-493e-9b6a-9adef67bc65f	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Retin-A	TRETINOIN	Bausch Health US, LLC	9556d73d-c573-4e0a-9feb-764ce2d1107b	2024-05-17	Adverse reactions	Name fallback generic name: TRETINOIN
Tretinoin	TRETINOIN	Alembic Pharmaceuticals Inc.	d6cc176c-ca71-481b-93c4-36565770a7b5	2024-05-01	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Zydus Lifesciences Limited	047989fc-6e33-4f19-8ba7-5fb63bb06cf3	2024-04-26		Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Viona Pharmaceuticals Inc	2ee7844c-e5ee-4d15-80c7-c07a9f23ccdd	2024-04-26	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
TRETINOIN	TRETINOIN	Bryant Ranch Prepack	5e84c976-d4d6-4d8f-a448-8afb47e2fbff	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: TRETINOIN generic name: TRETINOIN
Tretinoin	TRETINOIN	Oceanside Pharmaceuticals	febda58b-c9ee-4b95-bee7-dca5f2645f98	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Atralin	TRETINOIN	Bausch Health US, LLC	b6b45969-a64a-4ce3-b3b6-157d2568a301	2024-02-01	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN
TRETINOIN	TRETINOIN	A-S Medication Solutions	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	2024-01-28	Warnings, Adverse reactions	Name fallback brand name: TRETINOIN generic name: TRETINOIN
TRETINOIN	TRETINOIN	Padagis US LLC	4889c7f8-37d0-4f1a-9829-bca107806586	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: TRETINOIN generic name: TRETINOIN
Tretinoin	TRETINOIN	A-S Medication Solutions	c7860dcd-91b0-44e0-98d6-a843b16457e1	2023-10-25	Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Mylan Pharmaceuticals Inc.	ce5f4f14-5e60-4cc1-bcb3-1fa9b8aa9cd5	2022-07-25	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Tretinoin	TRETINOIN	Obagi Cosmeceuticals LLC	c5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b	2021-05-01	Warnings, Adverse reactions	Name fallback brand name: Tretinoin generic name: TRETINOIN
Altreno	TRETINOIN	Bausch Health US, LLC	1412aba5-71aa-4cce-8db4-c189bed1852c	2020-03-02	Warnings, Adverse reactions	Name fallback generic name: TRETINOIN

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0808	Tretinoin	Tretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0808	Tretinoin	Tretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0808	Tretinoin	Tretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0808	Tretinoin	Tretinoin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
63629-8752	Tretinoin	Tretinoin	Bryant Ranch Prepack	ANDA	Current
63629-8752	Tretinoin	Tretinoin	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9076	ORIG	2007-07-05