Home Applications 091553 Application 091553
Type ANDA
Sponsor PERRIGO ISRAEL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE LOTION;TOPICAL 0.05% 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 A091553-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL RS 2013-07-30
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 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL RS 2013-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL RS 2013-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL RS 2013-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091553-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2013-07-30 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 43538-970 Beser fluticasone propionate Medimetriks Pharmaceuticals, Inc. ANDA Current 43538-971 Beser Fluticasone propionate Medimetriks Pharmaceuticals, Inc ANDA Current 45802-441 fluticasone propionate fluticasone propionate Perrigo New York Inc ANDA Current 45802-441 fluticasone propionate fluticasone propionate Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-441 fluticasone propionate fluticasone propionate Perrigo New York Inc ANDA Current 45802-441 fluticasone propionate fluticasone propionate Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-441 fluticasone propionate fluticasone propionate Padagis Israel Pharmaceuticals Ltd ANDA Current