Home Applications 208279 Application 208279
Type ANDA
Sponsor GLENMARK PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRETINOIN TRETINOIN CAPSULE;ORAL 10MG 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 A208279-001 TRETINOIN TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208279-001 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 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tretinoin TRETINOIN Glenmark Pharmaceuticals Inc., USA 264138c1-9e5f-45ef-be87-79ca97c989d9 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208279 application number: ANDA208279 ndc (product): 68462-792
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42291-870 Tretinoin Tretinoin AvKARE ANDA Current 68462-792 Tretinoin Tretinoin Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-792 Tretinoin Tretinoin Glenmark Pharmaceuticals Inc., USA ANDA Current