Application 090962

Type: ANDA
Sponsor: P AND L

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADAPALENE	ADAPALENE	GEL;TOPICAL	0.1%	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
A090962-001	ADAPALENE	ADAPALENE	0.1%	GEL / TOPICAL			2010-06-02

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-06-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-06-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-06-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090962-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090962-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090962-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090962-001	AB	1	`ea99ee380514…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adapalene	ADAPALENE	Safeway, Inc.	a9816181-d643-4579-8b12-3927120dc627	2026-06-18	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	4dfe533e-d3dc-b7ff-e063-6394a90ac61b	2026-04-08	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	The Kroger Co.	1238c72c-1c51-46e4-b15c-61093b03608e	2026-03-23	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	P & L Development, LLC	e9155950-6c92-4f57-851a-51be6ba9062f	2025-12-16	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	YYBA CORP	44eb8cf6-d8ed-0e08-e063-6394a90ac8ef	2025-12-01	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	Topco Associates	5693e3c9-00e5-4e62-b44a-47be2dc31811	2025-10-06	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	3f9b75cf-75aa-9012-e063-6294a90a6469	2025-10-01	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	Meijer Distribution Inc.	f2c25c70-87b7-482f-b23a-467008761a3e	2025-09-09	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	Walgreens	2c1cdc03-087d-43b0-b0b3-503a35398a53	2025-05-16	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	Walgreens	84ab65a4-b343-4ad9-8049-aea1ec029031	2025-03-12	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Neutrogena Adapalene 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	0682cb55-6ae3-437f-e063-6294a90ac510	2024-11-12	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	CVS PHARMACY, INC	ff9a929e-121b-42b4-8e79-f8f46c22a8be	2024-02-21	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-6301	Adapalene	Adapalene	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6301	Adapalene	Adapalene	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-6301	Adapalene	Adapalene	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9308	ORIG	2010-06-08