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 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
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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022502-001	DIFFERIN	0.1%	LOTION / TOPICAL	RLD	2010-03-17	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022502-001	8435502	2026-09-15	U-1078	Drug product	2013-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022502-001	8709392	2026-09-15	U-1078	Drug product	2014-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022502-001	7998467	2028-05-31	U-1078	Drug product	2011-08-19	`caaa826d4ba7…`
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…`

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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adapalene	ADAPALENE	Topco Associates	5693e3c9-00e5-4e62-b44a-47be2dc31811	2025-10-06	Warnings	Name fallback generic name: ADAPALENE
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	3f9b75cf-75aa-9012-e063-6294a90a6469	2025-10-01	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Meijer Distribution Inc.	f2c25c70-87b7-482f-b23a-467008761a3e	2025-09-09	Warnings	Name fallback generic name: ADAPALENE
ADAPALENE	ADAPALENE	Target Corporation	164f52fa-3050-3eea-e063-6394a90a6f70	2025-09-08	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	62fab99a-f91b-4f0f-9143-9c9bc69df759	2025-08-25	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	CVS Pharmacy	7fb758ce-4f15-4130-8612-9113a764b5cd	2025-08-25	Warnings	Name fallback generic name: ADAPALENE
PanOxyl	ADAPALENE	CROWN LABORATORIES	3bdcb3d7-164e-e678-e063-6394a90a3d6b	2025-08-08	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	AMERISOURCE BERGEN	8d6e2e28-a11a-4443-a43b-098a55622e24	2025-07-02	Warnings	Name fallback generic name: ADAPALENE
ADAPALENE	ADAPALENE	Cardinal Health	d894d7ce-4c44-4092-88dd-8e8f7ef777f2	2025-07-02	Warnings	Name fallback generic name: ADAPALENE
ADAPALENE	ADAPALENE	RITE AID	0c96c096-73f8-5bc2-e063-6294a90a235f	2025-07-02	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	YYBA Corp	2d7f95d1-2f9a-1623-e063-6294a90a6724	2025-07-02	Warnings	Name fallback generic name: ADAPALENE
PanOxyl	ADAPALENE	CROWN LABORATORIES	40f8d9e1-d1b9-464b-92ba-9695d419a6f7	2025-07-02	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	YYBA CORP	3ab5661b-a67a-45a3-b542-228be3cebb27	2025-07-02	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Sun Pharmaceutical Industries, Inc.	a9ca1f7a-71c3-4814-9366-e7e5760bf32c	2025-05-15	Warnings	Name fallback generic name: ADAPALENE
ADAPALENE	ADAPALENE	Alembic Pharmaceuticals Limited	5dd6d825-f7c4-4a86-82cc-fcbb41df8542	2025-03-26	Warnings, Adverse reactions	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Walgreens	84ab65a4-b343-4ad9-8049-aea1ec029031	2025-03-12	Warnings	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	CALL INC. (dba Rochester Pharmaceuticals)	5ce78048-0e5c-45b5-82bf-9f61307611cd	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: ADAPALENE
Neutrogena Adapalene 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	0682cb55-6ae3-437f-e063-6294a90ac510	2024-11-12	Warnings	Name fallback generic name: ADAPALENE
ADAPALENE	ADAPALENE	Alembic Pharmaceuticals Inc.	a3b6f3c3-d615-4b00-a76f-134b75e30a50	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: ADAPALENE
adapalene	ADAPALENE	Actavis Pharma, Inc.	aacd5ec4-e2fa-460e-aaae-a0aba5c052e5	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: ADAPALENE

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 · 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