Home Applications 209596 Application 209596
Type ANDA
Sponsor GLASSHOUSE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE SOLUTION;TOPICAL 0.01% 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 A209596-001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209596-001 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 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209596-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2017-12-26 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 2 of 3 · 42 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join fluocinolone acetonide FLUOCINOLONE ACETONIDE Padagis Israel Pharmaceuticals Ltd ba20d901-f800-4edd-aac6-6c77cbfe1064 2025-07-31 Warnings, Adverse reactions Name fallback brand name: fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Padagis Israel Pharmaceuticals Ltd e6af2549-50b5-4b7f-a0c0-de0f7626b6f3 2025-07-31 Warnings, Adverse reactions Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE Fluocinolone acetonide FLUOCINOLONE ACETONIDE Padagis Israel Pharmaceuticals Ltd 7f8512d9-b4a4-43c6-bac6-3e75dc451db2 2025-07-31 Warnings, Adverse reactions Name fallback brand name: Fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide Oil FLUOCINOLONE ACETONIDE A-S Medication Solutions 0ff97af2-04d6-478e-8abe-ca5a0c675708 2025-07-10 Adverse reactions Name fallback generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Sun Pharmaceutical Industries, Inc. 02352ed1-3568-441f-add8-45201351a11c 2025-07-03 Adverse reactions Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Sun Pharmaceutical Industries, Inc. 22e9909a-47d2-4331-9b92-e7c4c2acf739 2025-07-02 Warnings, Adverse reactions Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE DERMOTIC FLUOCINOLONE ACETONIDE Royal Pharmaceuticals eb00f222-8105-4e05-90e8-bbd129784364 2025-05-09 Warnings, Adverse reactions Name fallback generic name: FLUOCINOLONE ACETONIDE Flac Otic Oil FLUOCINOLONE ACETONIDE Patrin Pharma, Inc. 4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb 2024-11-19 Adverse reactions Name fallback generic name: FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE Bryant Ranch Prepack 7954bdec-1b75-41d1-8c19-500eceaf6655 2024-11-08 Adverse reactions Name fallback brand name: FLUOCINOLONE ACETONIDE generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Bryant Ranch Prepack 8ca4528d-7afa-451e-97ae-9c1c21c07a6e 2024-10-18 Warnings, Adverse reactions Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE Synalar FLUOCINOLONE ACETONIDE Medimetriks Pharmaceuticals, Inc. 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d 2024-07-18 Adverse reactions Name fallback generic name: FLUOCINOLONE ACETONIDE Fluocinolone acetonide FLUOCINOLONE ACETONIDE Bryant Ranch Prepack c9e2b99e-1f64-4c21-99a7-a18963be2237 2024-05-24 Adverse reactions Name fallback brand name: Fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE fluocinolone acetonide FLUOCINOLONE ACETONIDE Bryant Ranch Prepack 71541422-f12c-4e92-8012-dba59112070c 2024-04-12 Warnings, Adverse reactions Name fallback brand name: fluocinolone acetonide generic name: FLUOCINOLONE ACETONIDE Synalar FLUOCINOLONE ACETONIDE Medimetriks Pharmaceuticals, Inc. d2d155cf-a635-4ab7-87de-34e90b9a74cd 2023-11-29 Adverse reactions Name fallback generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Cosette Pharmaceuticals, Inc. de5b78ab-ff79-3e0f-cad4-ecab11ebbdcd 2023-11-22 Adverse reactions Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Quagen Pharmaceuticals LLC a625fe98-8630-4b27-b2fc-4b045847d8f1 2023-02-26 Warnings, Adverse reactions Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Quagen Pharmaceuticals LLC fa5eba5b-57bf-4d46-b0e1-c7104542cb46 2023-02-26 Adverse reactions Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE Quagen Pharmaceuticals LLC 2bcea813-d629-42c5-8953-fa231b4cbf58 2023-02-26 Adverse reactions Name fallback brand name: FLUOCINOLONE ACETONIDE generic name: FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE Cosette Pharmaceuticals, Inc. a6e77bc5-ddb3-491a-bf16-d6d253886bb0 2022-11-16 Adverse reactions Name fallback brand name: FLUOCINOLONE ACETONIDE generic name: FLUOCINOLONE ACETONIDE Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Lupin Pharmaceuticals,Inc. 460f5a55-6437-4651-bc08-8063ca579c8d 2019-02-21 Adverse reactions Name fallback brand name: Fluocinolone Acetonide generic name: FLUOCINOLONE ACETONIDE
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 10135-670 fluocinolone acetonide fluocinolone acetonide Marlex Pharmaceuticals Inc ANDA Current 10135-670 fluocinolone acetonide fluocinolone acetonide Marlex Pharmaceuticals Inc ANDA Current 10135-670 fluocinolone acetonide fluocinolone acetonide Marlex Pharmaceuticals Inc ANDA Current 71428-002 Fluocinolone Acetonide Fluocinolone Acetonide Glasshouse Pharmaceuticals Limited Canada ANDA Current 71428-002 Fluocinolone Acetonide Fluocinolone Acetonide Glasshouse Pharmaceuticals Limited Canada ANDA Current 71428-002 Fluocinolone Acetonide Fluocinolone Acetonide Glasshouse Pharmaceuticals Limited Canada ANDA Current 71428-002 Fluocinolone Acetonide Fluocinolone Acetonide Glasshouse Pharmaceuticals Limited Canada ANDA Current