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 3 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adapalene	ADAPALENE	CVS PHARMACY, INC	ff9a929e-121b-42b4-8e79-f8f46c22a8be	2024-02-21	Warnings	Name fallback generic name: ADAPALENE
DIFFERIN	ADAPALENE	Galderma Laboratories, L.P.	a0031324-92a6-4c11-90e2-c2818f7278ec	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: DIFFERIN generic name: ADAPALENE
Adapalene	ADAPALENE	Padagis Israel Pharmaceuticals Ltd	94cf9af1-afab-4064-a2ca-619b54218262	2023-07-25	Adverse reactions	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	MEIJER, INC.	74715ce7-351f-495b-8637-57d809815681	2023-07-10	Warnings	Name fallback generic name: ADAPALENE
Differin	ADAPALENE	Galderma Laboratories, L.P.	0739d631-171b-42a8-bd55-0022b8df2d8a	2022-12-07	Warnings	Name fallback brand name: Differin generic name: ADAPALENE
ADAPALENE	ADAPALENE	Mayne Pharma Commercial LLC.	9a0d9a0d-a9f3-4eb9-be76-166ef182d13a	2022-11-28	Warnings, Adverse reactions	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	LOreal USA Products Inc	24e0fd2f-05dc-4ff4-838f-ee022a3a9c20	2019-11-25	Warnings	Name fallback generic name: ADAPALENE
Effaclar	ADAPALENE	LOreal USA Products Inc	a47b204a-3815-4a2b-9a7d-2c2b65b837bb	2019-08-23	Warnings	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