Application 022502

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIFFERIN	ADAPALENE	LOTION;TOPICAL	0.1%	Yes	Yes

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
N022502-001	DIFFERIN	ADAPALENE	0.1%	LOTION / TOPICAL		RLD	2010-03-17

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22
N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16
N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD, RS	2010-03-17	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`8072bd15b7f6…`

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 · 49 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	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Sun Pharmaceutical Industries, Inc.	ca37576a-09aa-4ee8-9dc4-8ad76b999fcf	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: ADAPALENE
ADAPALENE	ADAPALENE	RUGBY LABORATORIES, INC.	330bc2b3-e064-4189-9c47-9c5a50aa4dde	2026-06-01	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	TOP CARE (Topco Associates LLC)	07351ab9-ed46-4ef8-85f3-bb6cc7af17c3	2026-05-19	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Bryant Ranch Prepack	5f8189a2-a7ec-441b-993c-fed28b3ae24f	2026-04-15	Adverse reactions	Name fallback generic name: ADAPALENE
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	4dfe533e-d3dc-b7ff-e063-6394a90ac61b	2026-04-08	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Bryant Ranch Prepack	79454b4c-3fd4-4e6d-b984-908f8cc8ab6d	2026-04-07	Adverse reactions	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	The Kroger Co.	1238c72c-1c51-46e4-b15c-61093b03608e	2026-03-23	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	YYBA Corp	47d3a5f5-410c-288f-e063-6294a90a0d92	2026-02-03	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	GLENMARK THERAPEUTICS INC., USA	42c1c354-2c00-4bc2-bbd3-a5dd5ff9a208	2026-01-31	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	GLENMARK THERAPEUTICS INC., USA	ec6811f7-4728-41b1-8647-d63bb135e24e	2026-01-31	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	276f7cce-5f54-40f8-8321-9192d0e52a73	2026-01-30	Adverse reactions	Name fallback generic name: ADAPALENE
Curist Acne Relief	ADAPALENE	Little Pharma, Inc.	e6380880-5299-0826-e053-2a95a90a1942	2026-01-11	Warnings	Name fallback generic name: ADAPALENE
Proactiv MD Adapalene Acne Treatment	ADAPALENE	Alchemee, LLC	0a9b3755-c0db-4282-e063-6394a90a0c08	2026-01-07	Warnings	Name fallback generic name: ADAPALENE
Effaclar	ADAPALENE	LOreal USA Products Inc	e94854c5-6bb8-43db-b898-4d47a419d075	2025-12-23	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	P & L Development, LLC	e9155950-6c92-4f57-851a-51be6ba9062f	2025-12-16	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Wal-Mart Stores Inc	36eb4a78-3a7e-b39f-e063-6394a90ad159	2025-12-16	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Walgreens	53087d52-3fef-4d28-b2ef-93470e3e19b5	2025-12-11	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	YYBA CORP	44eb8cf6-d8ed-0e08-e063-6394a90ac8ef	2025-12-01	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Topco Associates	5693e3c9-00e5-4e62-b44a-47be2dc31811	2025-10-06	Warnings	Name fallback generic name: ADAPALENE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-5912	Differin	adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-5912	Differin	adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-5912	Differin	adapalene	Galderma Laboratories, L.P.	NDA	Current
69007-912	adapalene	adapalene	Owen Laboratories, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74032	SUPPL	2023-04-20
74030	SUPPL	2023-04-20
71942	SUPPL	2022-08-29
29787	SUPPL	2013-04-23
17649	SUPPL	2013-04-23
24325	ORIG	2010-08-30
22037	ORIG	2010-08-30
7464	ORIG	2010-03-22
38768	ORIG	2010-03-18
53156	ORIG	1900-01-01
53155	ORIG	1900-01-01
53154	ORIG	1900-01-01