Home Applications 091314 Application 091314
Type ANDA
Sponsor GLENMARK GENERICS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ADAPALENE ADAPALENE GEL;TOPICAL 0.1% No No 002 ADAPALENE ADAPALENE GEL;TOPICAL 0.1% No No
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 A091314-001 ADAPALENE ADAPALENE 0.1% GEL / TOPICAL 2010-07-01
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 · 44 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 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091314-001 ADAPALENE 0.1% GEL / TOPICAL AB 2010-07-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091314-002 ADAPALENE 0.1% GEL / TOPICAL 2019-07-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091314-001 ADAPALENE 0.1% GEL / TOPICAL AB 2010-07-01 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A091314-002 ADAPALENE 0.1% GEL / TOPICAL 2019-07-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091314-001 ADAPALENE 0.1% GEL / TOPICAL AB 2010-07-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A091314-002 ADAPALENE 0.1% GEL / TOPICAL 2019-07-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091314-001 ADAPALENE 0.1% GEL / TOPICAL AB 2010-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 3a93d1ddd44b…
Observed Orange Book normalized TE history# 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 · 15 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 35 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0888 Adapalene Adapalene Walgreens ANDA Current 0363-0888 Adapalene Adapalene Walgreens ANDA Current 0363-0888 Adapalene Adapalene Walgreens ANDA Current 11673-888 Adapalene Adapalene TARGET Corporation ANDA Current 11673-888 Adapalene Adapalene TARGET Corporation ANDA Current 11673-888 Adapalene Adapalene TARGET Corporation ANDA Current 21130-708 Adapalene Adapalene Safeway, Inc. ANDA Current 21130-708 Adapalene Adapalene Safeway, Inc. ANDA Current 21130-708 Adapalene Adapalene Safeway, Inc. ANDA Current 36800-088 Adapalene Adapalene TOP CARE (Topco Associates LLC) ANDA Current 36800-088 Adapalene Adapalene TOP CARE (Topco Associates LLC) ANDA Current 41250-288 Adapalene Adapalene MEIJER, INC. ANDA Current 41250-288 Adapalene Adapalene MEIJER, INC. ANDA Current 42546-720 Adapalene Adapalene PruGen, Inc. ANDA Current 49967-354 Adapalene Adapalene L ANDA Current 49967-591 Effaclar Adapalene L ANDA Current 50090-2004 Adapalene Adapalene A-S Medication Solutions ANDA Current 50090-2004 Adapalene Adapalene A-S Medication Solutions ANDA Current 55910-880 Adapalene Adapalene Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 55910-880 Adapalene Adapalene Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 59726-888 Adapalene Adapalene P & L Development, LLC ANDA Current 59726-888 Adapalene Adapalene P & L Development, LLC ANDA Current 68462-403 Adapalene Adapalene Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-403 Adapalene Adapalene Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-403 Adapalene Adapalene Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-403 Adapalene Adapalene Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-403 Adapalene Adapalene Glenmark Pharmaceuticals Inc., USA ANDA Current 69842-088 Adapalene Adapalene CVS Pharmacy ANDA Current 70000-0043 Adapalene Adapalene Cardinal Health (Leader) 70000 ANDA Current 70000-0043 Adapalene Adapalene Cardinal Health (Leader) 70000 ANDA Current 70000-0043 Adapalene Adapalene Cardinal Health (Leader) 70000 ANDA Current 72559-015 Curist Acne Relief Adapalene Little Pharma, Inc. ANDA Current 72657-102 Adapalene Adapalene Glenmark Pharmaceuticals Inc., USA ANDA Current 82034-888 Adapalene Adapalene Stryke Club, Inc. ANDA Current 82034-888 Adapalene Adapalene Stryke Club, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 65845 ORIG 2021-01-07