Home Applications 211111 Application 211111
Type ANDA
Sponsor AMNEAL PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUOCINONIDE FLUOCINONIDE CREAM;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 A211111-001 FLUOCINONIDE FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04
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 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 e64feba35796…
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 · 1 matching rows.
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 68788-7541 Fluocinonide Fluocinonide Preferred Pharmaceuticals Inc. ANDA Current 68788-7541 Fluocinonide Fluocinonide Preferred Pharmaceuticals Inc. ANDA Current 69238-1271 Fluocinonide Fluocinonide Amneal Pharmaceuticals NY LLC ANDA Current 69238-1271 Fluocinonide Fluocinonide Amneal Pharmaceuticals NY LLC ANDA Current 69238-1271 Fluocinonide Fluocinonide Amneal Pharmaceuticals LLC ANDA Current 69238-1271 Fluocinonide Fluocinonide Amneal Pharmaceuticals NY LLC ANDA Current 76420-530 Fluocinonide Fluocinonide Asclemed USA, Inc. ANDA Current