Home Applications 208150 Application 208150
Type ANDA
Sponsor APOTEX 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 A208150-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29
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 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 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 1 · 17 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 2 of 2 · 130 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63654-380 Fluticasone Propionate Fluticasone Propionate Selder, S.A. de C.V. ANDA Current 63654-380 Fluticasone Propionate Fluticasone Propionate Selder, S.A. de C.V. ANDA Current 63654-380 Fluticasone Propionate Fluticasone Propionate Selder, S.A. de C.V. ANDA Current 63868-138 Fluticasone Propionate Fluticasone Propionate Chain Drug Marketing Association ANDA Current 63868-400 Fluticasone Propionate Fluticasone Propionate Chain Drug Marketing Association ANDA Current 63868-400 Fluticasone Propionate Fluticasone Propionate Chain Drug Marketing Association ANDA Current 63868-400 Fluticasone Propionate Fluticasone Propionate Chain Drug Marketing Association ANDA Current 63868-656 Fluticasone Propionate Fluticasone Propionate Chain Drug Marketing Association ANDA Current 63868-656 Fluticasone Propionate Fluticasone Propionate Chain Drug Marketing Association ANDA Current 64525-6560 Allergy Relief Fluticasone Propionate Quality Home Products ANDA Current 64525-6560 Allergy Relief Fluticasone Propionate Quality Home Products ANDA Current 64525-7000 Fluticasone Propionate Fluticasone Propionate Quality Home Products ANDA Current 64525-8000 Allergy Relief Fluticasone Propionate Quality Home Products ANDA Current 64525-8000 Allergy Relief Fluticasone Propionate Quality Home Products ANDA Current 68016-723 Fluticasone Propionate Fluticasone Propionate Chain Drugs Consortium, LLC ANDA Current 68016-723 Fluticasone Propionate Fluticasone Propionate Chain Drugs Consortium, LLC ANDA Current 68196-208 Fluticasone Propionate Fluticasone Propionate Sam's West Inc. ANDA Current 68196-208 Fluticasone Propionate Fluticasone Propionate Sam's West Inc. ANDA Current 68196-208 Fluticasone Propionate Fluticasone Propionate Sam's West Inc. ANDA Current 68196-208 Fluticasone Propionate Fluticasone Propionate Sam's West Inc. ANDA Current 68196-210 Fluticasone Propionate Fluticasone Propionate Sam's West Inc. ANDA Current 68196-210 Fluticasone Propionate Fluticasone Propionate Sam's West Inc. ANDA Current 68196-210 Fluticasone Propionate Fluticasone Propionate Sam's West Inc. ANDA Current 68998-100 Fluticasone Propionate Fluticasone Propionate Marc Glassman, Inc. ANDA Current 68998-600 Fluticasone Propionate Fluticasone Propionate Marc Glassman, Inc. ANDA Current 68998-600 Fluticasone Propionate Fluticasone Propionate Marc Glassman, Inc. ANDA Current 68998-600 Fluticasone Propionate Fluticasone Propionate Marc Glassman, Inc. ANDA Current 69168-380 Fluticasone Propionate Fluticasone Propionate Allegiant Health ANDA Current 69168-380 Fluticasone Propionate Fluticasone Propionate Allegiant Health ANDA Current 69168-380 Fluticasone Propionate Fluticasone Propionate Allegiant Health ANDA Current 69168-380 Fluticasone Propionate Fluticasone Propionate Allegiant Health ANDA Current 69842-000 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-020 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-228 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-228 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-530 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-765 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-765 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-765 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-765 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-770 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-770 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-770 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 69842-770 Fluticasone Propionate Fluticasone Propionate CVS Pharmacy ANDA Current 72559-002 Fluticasone Propionate Fluticasone Propionate Little Pharma, Inc. ANDA Current 72559-002 Fluticasone Propionate Fluticasone Propionate Little Pharma, Inc. ANDA Current 72559-002 Fluticasone Propionate Fluticasone Propionate Little Pharma, Inc. ANDA Current 72559-002 Fluticasone Propionate Fluticasone Propionate Little Pharma, Inc. ANDA Current 76162-656 Allergy Relief Fluticasone Propionate Topco Associates LLC ANDA Current 76162-656 Allergy Relief Fluticasone Propionate Topco Associates LLC ANDA Current