Home Applications 089524 Application 089524
Type ANDA
Sponsor ACP NIMBLE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OINTMENT;TOPICAL 0.025% 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 A089524-001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089524-001 AT
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 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089524-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1988-07-26 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.
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 0713-0224 Fluocinolone Acetonide Fluocinolone Acetonide Cosette Pharmaceuticals, Inc. ANDA Current 0713-0224 Fluocinolone Acetonide Fluocinolone Acetonide ACP Nimble Buyer, Inc. ANDA Current 0713-0224 Fluocinolone Acetonide Fluocinolone Acetonide Cosette Pharmaceuticals, Inc. ANDA Current