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 3 of 6 · 117 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluticasone Propionate FLUTICASONE PROPIONATE Apotex Corp. e3c861e3-2507-9758-fcd0-8e82d721b5b4 2026-03-06 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE RUGBY FLUTICASONE PROPIONATE NASAL FLUTICASONE PROPIONATE A-S Medication Solutions 0c4eb6cb-abc9-4945-8f30-cfa8b9eb579c 2026-02-24 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Topcare Allergy Relief Nasal FLUTICASONE PROPIONATE Topco Associates LLC 4586256c-cc86-4792-92ef-5a65a35d6377 2026-02-19 Warnings Name fallback generic name: FLUTICASONE PROPIONATE RUGBY FLUTICASONE PROPIONATE NASAL FLUTICASONE PROPIONATE ASCLEMED USA INC. e38d8796-b08c-49a8-94b8-0c2fdeb52a81 2026-02-10 Warnings Name fallback generic name: FLUTICASONE PROPIONATE exchange select allergy relief FLUTICASONE PROPIONATE Army & Air Force Exchange Service f15d5c04-e308-4540-8c0a-d66a44c3d4fd 2026-02-10 Warnings Name fallback generic name: FLUTICASONE PROPIONATE RUGBY FLUTICASONE PROPIONATE NASAL FLUTICASONE PROPIONATE Sportpharm LLC 95765842-415e-438b-8105-f6d93cddbdd0 2026-02-09 Warnings Name fallback generic name: FLUTICASONE PROPIONATE 24 Hour Allergy Nasal FLUTICASONE PROPIONATE Walgreen Company 7698b73f-16f4-4b99-a3be-9453e8c35469 2026-02-05 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Advagen Pharma Ltd 2c1c465c-d008-470e-aa48-8b44bd60751c 2026-02-04 Warnings, Adverse reactions Name fallback brand name: FLUTICASONE PROPIONATE generic name: FLUTICASONE PROPIONATE 365 WHOLE FOODS MARKET FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Whole Foods Market, Inc. 313517bd-cb08-49a5-8ef1-e5522cc21c80 2026-01-22 Warnings Name fallback generic name: FLUTICASONE PROPIONATE leader fluticasone propionate FLUTICASONE PROPIONATE Cardinal Health 110, LLC. dba Leader 14bb5d74-0384-417e-a06b-8868d85234dd 2026-01-21 Warnings Name fallback generic name: FLUTICASONE PROPIONATE DG Health Allergy Relief Nasal FLUTICASONE PROPIONATE Dolgencorp Inc 5f0514bd-7893-4602-a17b-716fb9947572 2026-01-21 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Foster and Thrive Allergy Relief FLUTICASONE PROPIONATE Strategic Sourcing Services LLC 67899c15-e5e5-4fe6-a639-71832969a761 2026-01-21 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate HFA FLUTICASONE PROPIONATE Preferred Pharmaceuticals Inc. ff1cf174-ae6f-45f0-a081-26a34e55f9ea 2026-01-20 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE NuCare Pharmaceuticals, Inc. 4849c4e5-58ea-972c-e063-6394a90a809c 2026-01-13 Warnings, Adverse reactions Name fallback brand name: FLUTICASONE PROPIONATE generic name: FLUTICASONE PROPIONATE XHANCE FLUTICASONE PROPIONATE OptiNose US, Inc. c79bbb9f-e483-4093-8c92-ea978e7bf278 2026-01-12 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE allergy relief nasal FLUTICASONE PROPIONATE Publix Super Markets Inc a70e26c8-2f50-49ac-8278-fc06e4c63e6a 2026-01-08 Warnings Name fallback generic name: FLUTICASONE PROPIONATE RUGBY FLUTICASONE PROPIONATE NASAL FLUTICASONE PROPIONATE Rugby Laboratories 5227df05-f2c2-4bc4-91ee-da0fd03d1095 2026-01-08 Warnings Name fallback generic name: FLUTICASONE PROPIONATE good neighbor pharmacy fluticasone propionate FLUTICASONE PROPIONATE Amerisource Bergen b12ddc59-b689-48ac-9a40-2b9ae04a1312 2026-01-08 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Kirkland Signature Aller Flo FLUTICASONE PROPIONATE Costco Wholesale Company bf120a48-cc29-4f40-b70d-415868ac9d3e 2026-01-06 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Allergy Relief FLUTICASONE PROPIONATE Meijer Distribution Inc b69241d8-f019-43fe-b12b-25edcf01df40 2025-12-12 Warnings 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