Home Applications 203981 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 42 .
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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 A203981-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-09-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 3 · 50 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Adapalene ADAPALENE Walgreens 2c1cdc03-087d-43b0-b0b3-503a35398a53 2026-08-21 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPLANE 0.1% Acne Free, LLC 0dc574e0-397a-7bc8-e063-6394a90a27e2 2026-07-31 Warnings Name fallback brand name: Adapalene Adapalene ADAPALENE Safeway, Inc. a9816181-d643-4579-8b12-3927120dc627 2026-06-18 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE Sun Pharmaceutical Industries, Inc. ca37576a-09aa-4ee8-9dc4-8ad76b999fcf 2026-06-03 Warnings, Adverse reactions Name fallback brand name: Adapalene generic name: ADAPALENE ADAPALENE ADAPALENE RUGBY LABORATORIES, INC. 330bc2b3-e064-4189-9c47-9c5a50aa4dde 2026-06-01 Warnings Name fallback brand name: ADAPALENE generic name: ADAPALENE Adapalene ADAPALENE TOP CARE (Topco Associates LLC) 07351ab9-ed46-4ef8-85f3-bb6cc7af17c3 2026-05-19 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE Bryant Ranch Prepack 5f8189a2-a7ec-441b-993c-fed28b3ae24f 2026-04-15 Adverse reactions Name fallback brand name: Adapalene generic name: ADAPALENE Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment ADAPALENE Kenvue Brands LLC 4dfe533e-d3dc-b7ff-e063-6394a90ac61b 2026-04-08 Warnings Name fallback generic name: ADAPALENE Adapalene ADAPALENE Bryant Ranch Prepack 79454b4c-3fd4-4e6d-b984-908f8cc8ab6d 2026-04-07 Adverse reactions Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE The Kroger Co. 1238c72c-1c51-46e4-b15c-61093b03608e 2026-03-23 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE YYBA Corp 47d3a5f5-410c-288f-e063-6294a90a0d92 2026-02-03 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE GLENMARK THERAPEUTICS INC., USA 42c1c354-2c00-4bc2-bbd3-a5dd5ff9a208 2026-01-31 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE GLENMARK THERAPEUTICS INC., USA ec6811f7-4728-41b1-8647-d63bb135e24e 2026-01-31 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 276f7cce-5f54-40f8-8321-9192d0e52a73 2026-01-30 Adverse reactions Name fallback brand name: Adapalene generic name: ADAPALENE Curist Acne Relief ADAPALENE Little Pharma, Inc. e6380880-5299-0826-e053-2a95a90a1942 2026-01-11 Warnings Name fallback generic name: ADAPALENE Proactiv MD Adapalene Acne Treatment ADAPALENE Alchemee, LLC 0a9b3755-c0db-4282-e063-6394a90a0c08 2026-01-07 Warnings Name fallback generic name: ADAPALENE Effaclar ADAPALENE LOreal USA Products Inc e94854c5-6bb8-43db-b898-4d47a419d075 2025-12-23 Warnings Name fallback generic name: ADAPALENE Adapalene ADAPALENE P & L Development, LLC e9155950-6c92-4f57-851a-51be6ba9062f 2025-12-16 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE Wal-Mart Stores Inc 36eb4a78-3a7e-b39f-e063-6394a90ad159 2025-12-16 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE Adapalene ADAPALENE Walgreens 53087d52-3fef-4d28-b2ef-93470e3e19b5 2025-12-11 Warnings Name fallback brand name: Adapalene generic name: ADAPALENE
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