Home Applications 090759 Application 090759
Type ANDA
Sponsor GLENMARK GENERICS 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 44 .
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 A090759-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02
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 · 44 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 2026-10-15 13:18:30 2026-09 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 3a93d1ddd44b…
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 6 of 6 · 117 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FLOVENT HFA FLUTICASONE PROPIONATE A-S Medication Solutions 74563f7b-8512-4b76-8c55-b88b9cd3206b 2023-12-09 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Padagis Israel Pharmaceuticals Ltd 16985600-3f81-4d51-8bf7-0cbbd89856a1 2023-11-30 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Allegiant Health a4e1c265-5205-4089-8190-0755ede83896 2023-11-28 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Cosette Pharmaceuticals, Inc. e7ef2aaf-749c-66c9-2bdf-7214ab00060e 2023-11-22 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate HFA FLUTICASONE PROPIONATE A-S Medication Solutions 4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d 2023-11-17 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 8bd6f3a4-87f7-449e-8fcc-fec1537fcab3 2023-07-17 Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 0120296b-bebc-4a2d-8058-6caf41f96e52 2023-07-17 Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE A-S Medication Solutions e2df3810-3b92-4678-8f62-683c656b1de9 2023-04-16 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Padagis Israel Pharmaceuticals Ltd 78e056e2-d39e-4d20-9ab2-332bd6973619 2022-12-30 Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE topcare fluticasone propionate nasal FLUTICASONE PROPIONATE Topco Associates LLC f7c425d2-4afb-478f-83bc-eb336910233b 2022-11-01 Warnings Name fallback generic name: FLUTICASONE PROPIONATE equate allergy relief FLUTICASONE PROPIONATE Wal-Mart Stores Inc 959167e8-f4a1-49b9-b3a6-f0d0b3d7d477 2022-10-14 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Asclemed USA, Inc. 75049554-64ca-4efa-b8d1-13cf31d0ff90 2022-10-12 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Cosette Pharmaceuticals, Inc. 14c8d082-b301-8f09-a509-950459ae0a28 2022-05-05 Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Proficient Rx LP 96af29b8-16b4-4113-9ec3-338438e11a49 2019-11-01 Adverse reactions Name fallback brand name: FLUTICASONE PROPIONATE generic name: FLUTICASONE PROPIONATE FLOVENT DISKUS FLUTICASONE PROPIONATE Proficient Rx LP 816e929e-6ba0-437d-80bb-00068419ed53 2019-11-01 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Selder, S.A. de C.V. 2da4ba91-c356-473d-b20c-5bb9265767df 2017-11-29 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Allegiant Health 4e1cd546-4598-115b-0357-5d0c22731faa 2017-11-17 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 68462-427 Fluticasone Propionate Fluticasone Propionate Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-427 Fluticasone Propionate Fluticasone Propionate Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-427 Fluticasone Propionate Fluticasone Propionate Glenmark Pharmaceuticals Inc., USA ANDA Current