Home Applications 207957 Application 207957
Type ANDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE SPRAY, METERED;NASAL 0.05MG/SPRAY No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A207957-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26
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 · 43 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 2026-09-14 22:38:34 2026-08 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 f41ea6bd6efb…
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 3 · 43 matching rows.
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 3 of 3 · 166 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 80267-000 betr allergy relief nasal Fluticasone propionate Live Betr LLC ANDA Current 80267-000 betr allergy relief nasal Fluticasone propionate Live Betr LLC ANDA Current 81522-002 caring mill allergy relief nasal Fluticasone propionate FSA Store Inc. ANDA Current 81522-002 caring mill allergy relief nasal Fluticasone propionate FSA Store Inc. ANDA Current 81522-005 caring mill childrens allergy relief nasal Fluticasone Propionate FSA Store Inc. ANDA Current 81522-005 caring mill childrens allergy relief nasal Fluticasone Propionate FSA Store Inc. ANDA Current