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 5 of 6 · 117 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join allergy nasal FLUTICASONE PROPIONATE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 2aee623c-602a-407c-b7a3-e29928d7dfed 2024-12-18 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE A-S Medication Solutions 3b1849e1-bd0b-42e4-a4ac-f156dc18604a 2024-11-06 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate HFA FLUTICASONE PROPIONATE A-S Medication Solutions faaa1436-dafb-4f65-b062-b51b902f43c5 2024-10-29 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Proficient Rx LP 1d5d5f27-6565-4e7b-9923-faa3d15cb1c4 2024-10-01 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Proficient Rx LP ab8c172b-c369-4372-95f9-dd1a28b3982b 2024-10-01 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone FLUTICASONE PROPIONATE NuCare Pharmaceuticals,Inc. 549ff4f2-fa68-3dd8-e054-00144ff8d46c 2024-07-15 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE NuCare Pharmaceuticals,Inc. 8761a5e1-a9cb-0622-e053-2a95a90a3504 2024-06-14 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE CHILDRENS ALLERGY FLUTICASONE PROPIONATE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED b9b3efe4-2f5c-4d22-80a4-d15fb266fb23 2024-06-12 Warnings Name fallback generic name: FLUTICASONE PROPIONATE fluticasone propionate FLUTICASONE PROPIONATE Padagis Israel Pharmaceuticals Ltd c4d361d4-d480-4fb2-8cc7-4cc3e57838dc 2024-05-01 Warnings, Adverse reactions Name fallback brand name: fluticasone propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Allegiant Health 4250d331-17b0-46be-a779-fb4f09bade16 2024-04-11 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 96e0681d-3788-49cc-8c0e-3185675b8da1 2024-04-04 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack aed4ac53-cf6e-489e-bb7e-b8c444e4339e 2024-04-04 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack f6aca9a9-0310-4c11-84b2-eacd19c45a1d 2024-04-04 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 8204a0c2-bd24-409a-b848-b3b369df642f 2024-03-11 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE CHILDRENS FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE Haleon US Holdings LLC fab7a1f4-75e0-416f-9644-07aff08e6ab0 2024-03-05 Warnings Name fallback generic name: FLUTICASONE PROPIONATE CHILDRENS FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE Haleon US Holdings LLC 3adff80f-fca7-4cc5-b106-0f68f71c85b0 2024-02-08 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE DISKUS FLUTICASONE PROPIONATE A-S Medication Solutions 64d669da-559c-40f5-b649-2ce164c211ea 2024-01-30 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE A-S Medication Solutions 4a4b7242-1083-4912-a318-25c3914aaf22 2024-01-11 Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE FLOVENT DISKUS FLUTICASONE PROPIONATE A-S Medication Solutions 038e6c40-9421-40ef-874b-8f4d7110a74a 2024-01-11 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate HFA FLUTICASONE PROPIONATE A-S Medication Solutions 674b1c81-359d-4fc4-8ce6-a53931b171e0 2024-01-02 Warnings, Adverse reactions Name fallback 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