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 4 of 6 · 117 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CHILDRENS FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Aurohealth LLC 180ef101-dca6-496f-8376-63449d82d083 2025-12-08 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Aurohealth LLC 044a06a1-74fc-43ff-b136-37ad41220941 2025-12-08 Warnings Name fallback brand name: FLUTICASONE PROPIONATE generic name: FLUTICASONE PROPIONATE basic care allergy relief nasal FLUTICASONE PROPIONATE Amazon.com Services LLC 6e0628f6-bfdc-4c9d-8800-ffcdb93459f1 2025-11-25 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Equaline Fluticasone Propionate FLUTICASONE PROPIONATE United Natural Foods, Inc. dba UNFI dbaa5264-bbc9-411c-89bb-4aef3ee96459 2025-11-16 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 0cd0b88c-1ab3-4699-8eda-554054b8d33c 2025-10-30 Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Encube Ethicals, Inc. b734d397-e064-4d13-b0b5-fc89bd87f2e3 2025-10-27 Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Sam's West, Inc d2a6e22c-1159-c86a-b927-e7ace1d7023f 2025-10-24 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Hikma Pharmaceuticals USA Inc. 0d9a521b-8314-437c-8c9f-f6188f1134fe 2025-10-01 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bryant Ranch Prepack 36c0e343-5bd4-447e-8651-c5f44d2ffd7c 2025-09-24 Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Childrens Nasopro FLUTICASONE PROPIONATE H E B 607d0a22-72d1-440f-9dac-e088b68dde09 2025-08-11 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICARE FLUTICASONE PROPIONATE INNOVUS PHARMACEUTICALS, INC. fed545ab-6a85-4ce3-8651-370e279db49e 2025-07-16 Warnings Name fallback generic name: FLUTICASONE PROPIONATE DG Health childrens allergy relief nasal FLUTICASONE PROPIONATE Dolgencorp Inc 4dc4b47a-233c-4bb8-b08b-c07561c415ff 2025-06-03 Warnings Name fallback generic name: FLUTICASONE PROPIONATE basic care childrens allergy relief nasal FLUTICASONE PROPIONATE Amazon.com Services LLC cb4cb80a-9bc5-4e7b-a33b-fb462abf96c5 2025-05-23 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Bi-Mart 3e4ff2eb-0d99-4ce7-910e-81f878b2231e 2025-05-22 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE TWIN MED LLC 9337aa4b-382d-4ab9-b312-60417cdd40cf 2025-05-01 Warnings Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Asclemed USA, Inc. 6e2d11f9-94d8-4434-b46b-8e2fcc9276fb 2025-04-19 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE Good Sense 24 hour allergy nasal FLUTICASONE PROPIONATE RedPharm Drug, Inc f4c26992-c988-e20f-e053-2a95a90afb65 2025-01-23 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Asclemed USA, Inc. 504397c5-6f9f-45cc-9cc9-997da0a80364 2025-01-15 Warnings, Adverse reactions Name fallback brand name: Fluticasone Propionate generic name: FLUTICASONE PROPIONATE FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE Haleon US Holdings LLC b6134ba0-b70a-4eac-9a82-cef64b242c1d 2024-12-19 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Quality Care Products, LLC 1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e 2024-12-18 Warnings, Adverse reactions 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