Application 020338

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIFFERIN	ADAPALENE	SOLUTION;TOPICAL	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N020338-001	DIFFERIN	ADAPALENE	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	1996-05-31

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	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020338-001	DIFFERIN	0.1%	SOLUTION / TOPICAL	RLD	1996-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020338-001	DIFFERIN	0.1%	SOLUTION / TOPICAL	RLD	1996-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020338-001	DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL	RLD	1996-05-31	`f41ea6bd6efb…`

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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57645	ORIG	2019-02-15