Application 020380

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DIFFERIN	ADAPALENE	GEL;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
N020380-002	DIFFERIN	ADAPALENE	0.1%	GEL / TOPICAL		RLD, RS	2016-07-08

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	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020380-002	RTO	2019-07-08	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020380-002	RTO	2019-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020380-002	RTO	2019-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020380-002	RTO	2019-07-08	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Differin	ADAPALENE	Galderma Laboratories, L.P.	0739d631-171b-42a8-bd55-0022b8df2d8a	2022-12-07	Warnings	Exact identifier application applno (NDA): 020380 application number: NDA020380 ndc (product): 0299-4910

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-4910	Differin	Adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-4910	Differin	Adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-4910	Differin	Adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-4910	Differin	Adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-4910	Differin	Adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-4910	Differin	Adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-5910	DIFFERIN	adapalene	Galderma Laboratories, L.P.	NDA	Current
11410-956	Proactiv MD Adapalene	Adapalene	The Proactiv Company, LLC	NDA AUTHORIZED GENERIC	Current
11410-956	Proactiv MD Adapalene	Adapalene	Alchemee, LLC	NDA AUTHORIZED GENERIC	Current
51672-4155	Adapalene	Adapalene	Taro Pharmaceuticals U.S.A., Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79546	SUPPL	2024-09-06
71314	SUPPL	2022-06-15
53507	SUPPL	2018-03-29
53497	SUPPL	2018-03-28
49900	SUPPL	2017-10-02
48538	SUPPL	2017-05-25
48505	SUPPL	2017-05-24
47776	SUPPL	2017-03-30
47775	SUPPL	2017-03-30