Application 021753

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIFFERIN	ADAPALENE	GEL;TOPICAL	0.3%	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
N021753-001	DIFFERIN	ADAPALENE	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021753-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021753-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021753-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021753-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021753-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021753-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021753-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021753-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021753-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021753-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021753-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021753-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021753-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021753-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021753-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021753-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021753-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021753-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021753-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021753-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021753-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021753-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021753-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021753-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021753-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021753-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021753-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021753-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021753-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021753-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021753-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021753-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021753-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021753-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021753-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021753-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021753-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021753-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021753-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021753-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021753-001	7579377	2025-02-23	U-818			`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021753-001	7579377	2025-02-23	U-818			`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021753-001	7579377	2025-02-23	U-818			`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021753-001	7579377	2025-02-23	U-818			`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021753-001	7737181	2024-08-29		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021753-001	7579377	2025-02-23	U-818			`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021753-001	7737181	2024-08-29		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021753-001	7579377	2025-02-23	U-818			`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021753-001	7737181	2024-08-29		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021753-001	7579377	2025-02-23	U-818			`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021753-001	7737181	2024-08-29		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021753-001	7579377	2025-02-23	U-818			`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021753-001	7737181	2024-08-29		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021753-001	7579377	2025-02-23	U-818			`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021753-001	7737181	2024-08-29		Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021753-001	7579377	2025-02-23	U-818			`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021753-001	7737181	2024-08-29		Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021753-001	7579377	2025-02-23	U-818			`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021753-001	7737181	2024-08-29		Drug product		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021753-001	7579377	2025-02-23	U-818			`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021753-001	7737181	2024-08-29		Drug product		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021753-001	7579377	2025-02-23	U-818			`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7834060	2023-03-12	U-1078		2010-11-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7838558	2023-03-12		Drug product	2010-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7868044	2023-03-12	U-1078		2011-01-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	8703820	2023-03-12	U-1078		2014-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7737181	2024-08-29		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7579377	2025-02-23	U-818			`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7834060	2023-03-12	U-1078		2010-11-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7838558	2023-03-12		Drug product	2010-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7868044	2023-03-12	U-1078		2011-01-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	8703820	2023-03-12	U-1078		2014-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7737181	2024-08-29		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7579377	2025-02-23	U-818			`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7834060	2023-03-12	U-1078		2010-11-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7838558	2023-03-12		Drug product	2010-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7868044	2023-03-12	U-1078		2011-01-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	8703820	2023-03-12	U-1078		2014-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7737181	2024-08-29		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7579377	2025-02-23	U-818			`4b0b4de00fa7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIFFERIN	ADAPALENE	Galderma Laboratories, L.P.	a0031324-92a6-4c11-90e2-c2818f7278ec	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021753 application number: NDA021753 ndc (product): 0299-5918
ADAPALENE	ADAPALENE	Mayne Pharma Commercial LLC.	9a0d9a0d-a9f3-4eb9-be76-166ef182d13a	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021753 application number: NDA021753

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-5918	DIFFERIN	adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-5918	DIFFERIN	adapalene	Galderma Laboratories, L.P.	NDA	Current
0299-5918	DIFFERIN	adapalene	Galderma Laboratories, L.P.	NDA	Current
66993-884	ADAPALENE	ADAPALENE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
69007-918	adapalene	adapalene	Owen Laboratories, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77173	SUPPL	2024-01-02
77172	SUPPL	2024-01-02
77168	SUPPL	2023-12-29
77167	SUPPL	2023-12-29
71943	SUPPL	2022-08-29
71898	SUPPL	2022-08-26
28527	SUPPL	2014-06-18
16313	SUPPL	2012-02-27
37588	SUPPL	2010-09-07
28526	SUPPL	2010-09-07
42299	ORIG	2008-03-14
6125	ORIG	2007-07-05
16312	ORIG	2007-06-27