Application 203981

Type: ANDA
Sponsor: CALL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADAPALENE	ADAPALENE	SOLUTION;TOPICAL	0.1%	No	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
A203981-001	ADAPALENE	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB		2016-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203981-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203981-001	ADAPALENE	0.1%	SOLUTION / TOPICAL	AB	2016-09-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203981-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203981-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203981-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203981-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203981-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203981-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203981-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203981-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203981-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203981-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203981-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203981-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203981-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203981-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203981-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203981-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203981-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203981-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203981-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203981-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203981-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203981-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203981-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203981-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203981-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203981-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203981-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203981-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203981-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203981-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203981-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203981-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203981-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203981-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203981-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203981-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203981-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203981-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203981-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203981-001	AB	1	`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 · 49 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
adapalene	ADAPALENE	Actavis Pharma, Inc.	aacd5ec4-e2fa-460e-aaae-a0aba5c052e5	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: adapalene generic name: ADAPALENE
Adapalene	ADAPALENE	CVS PHARMACY, INC	ff9a929e-121b-42b4-8e79-f8f46c22a8be	2024-02-21	Warnings	Name fallback brand name: Adapalene generic name: ADAPALENE
DIFFERIN	ADAPALENE	Galderma Laboratories, L.P.	a0031324-92a6-4c11-90e2-c2818f7278ec	2023-12-27	Warnings, Adverse reactions	Name fallback generic name: ADAPALENE
Adapalene	ADAPALENE	Padagis Israel Pharmaceuticals Ltd	94cf9af1-afab-4064-a2ca-619b54218262	2023-07-25	Adverse reactions	Name fallback brand name: Adapalene generic name: ADAPALENE
Adapalene	ADAPALENE	MEIJER, INC.	74715ce7-351f-495b-8637-57d809815681	2023-07-10	Warnings	Name fallback brand name: Adapalene generic name: ADAPALENE
Differin	ADAPALENE	Galderma Laboratories, L.P.	0739d631-171b-42a8-bd55-0022b8df2d8a	2022-12-07	Warnings	Name fallback generic name: ADAPALENE
ADAPALENE	ADAPALENE	Mayne Pharma Commercial LLC.	9a0d9a0d-a9f3-4eb9-be76-166ef182d13a	2022-11-28	Warnings, Adverse reactions	Name fallback brand name: ADAPALENE generic name: ADAPALENE
Adapalene	ADAPALENE	LOreal USA Products Inc	24e0fd2f-05dc-4ff4-838f-ee022a3a9c20	2019-11-25	Warnings	Name fallback brand name: Adapalene 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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
28595-530	Adapalene	ADAPALENE	Allegis Pharmaceuticals, LLC	ANDA	Current
49908-117	Adapalene Topical Solution	Adapalene Topical Solution	CALL INC (d.b.a Rochester Pharmaceuticals)	ANDA	Current
49908-117	Adapalene Topical Solution	Adapalene Topical Solution	CALL INC (d.b.a Rochester Pharmaceuticals)	ANDA	Current
49908-117	Adapalene Topical Solution	Adapalene Topical Solution	CALL INC (d.b.a Rochester Pharmaceuticals)	ANDA	Current
71297-410	Adapalene Topical Solution	Adapalene Topical Solution	Allegis Holdings LLC	ANDA	Current
71297-410	Adapalene Topical Solution	Adapalene Topical Solution	Allegis Holdings LLC	ANDA	Current
71297-410	Adapalene Topical Solution	Adapalene Topical Solution	Allegis Holdings LLC	ANDA	Current