Application 201687

Type: ANDA
Sponsor: ANCHEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRETINOIN	TRETINOIN	CAPSULE;ORAL	10MG	No	No

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
A201687-001	TRETINOIN	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201687-001	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 1 of 2 · 41 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	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201687-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201687-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201687-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201687-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201687-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201687-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201687-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201687-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201687-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201687-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201687-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201687-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201687-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201687-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201687-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201687-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201687-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201687-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201687-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201687-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201687-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201687-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201687-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201687-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201687-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201687-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201687-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201687-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201687-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201687-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201687-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201687-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201687-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201687-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201687-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201687-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201687-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201687-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201687-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201687-001	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Major Pharmaceuticals	045258e2-5efb-4147-bf74-4c43af04dccc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201687 application number: ANDA201687 ndc (product): 0904-6867
Tretinoin	TRETINOIN	Par Health USA, LLC	9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201687 application number: ANDA201687 ndc (product): 10370-268
Tretinoin	TRETINOIN	American Health Packaging	b22d5a07-623a-4645-b87d-a151b86da8d5	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201687 application number: ANDA201687 ndc (product): 68084-075
Tretinoin	TRETINOIN	Bryant Ranch Prepack	7a7974c7-8b6c-41ae-9a48-a08a1439087a	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201687 application number: ANDA201687

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6867	Tretinoin	Tretinoin	Major Pharmaceuticals	ANDA	Current
0904-6867	Tretinoin	Tretinoin	Major Pharmaceuticals	ANDA	Current
0904-6867	Tretinoin	Tretinoin	Major Pharmaceuticals	ANDA	Current
0904-6867	Tretinoin	Tretinoin	Major Pharmaceuticals	ANDA	Current
10370-268	Tretinoin	Tretinoin	Par Pharmaceutical, Inc.	ANDA	Current
10370-268	Tretinoin	Tretinoin	Par Pharmaceutical, Inc.	ANDA	Current
42291-843	Tretinoin	Tretinoin	AvKARE, Inc.	ANDA	Current
42291-843	Tretinoin	Tretinoin	AvKARE	ANDA	Current
63629-2285	Tretinoin	Tretinoin	Bryant Ranch Prepack	ANDA	Current
63629-2285	Tretinoin	Tretinoin	Bryant Ranch Prepack	ANDA	Current
68084-075	Tretinoin	Tretinoin	American Health Packaging	ANDA	Current
68084-075	Tretinoin	Tretinoin	American Health Packaging	ANDA	Current
68084-075	Tretinoin	Tretinoin	American Health Packaging	ANDA	Current
68084-075	Tretinoin	Tretinoin	American Health Packaging	ANDA	Current