Home Applications 077570 Application 077570
Type ANDA
Sponsor HI TECH PHARMA 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 42 .
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 A077570-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16
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 · 42 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 2026-08-18 06:07:40 2026-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 e64feba35796…
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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 32 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-704 Fluticasone Propionate Fluticasone Propionate Rebel Distributors Corp ANDA Current 49999-982 Fluticasone Propionate Fluticasone Propionate Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ANDA Current 50090-2484 Fluticasone Propionate Fluticasone Propionate A-S Medication Solutions ANDA Current 50090-2484 Fluticasone Propionate Fluticasone Propionate A-S Medication Solutions ANDA Current 50090-2484 Fluticasone Propionate Fluticasone Propionate A-S Medication Solutions ANDA Current 50090-2557 Fluticasone Propionate Fluticasone Propionate A-S Medication Solutions ANDA Current 50090-2557 Fluticasone Propionate Fluticasone Propionate A-S Medication Solutions ANDA Current 50090-3513 Fluticasone Propionate Fluticasone Propionate A-S Medication Solutions ANDA Current 50090-4410 Fluticasone Propionate Fluticasone Propionate A-S Medication Solutions ANDA Current 50383-700 Fluticasone Propionate Fluticasone Propionate Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-700 Fluticasone Propionate Fluticasone Propionate Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-700 Fluticasone Propionate Fluticasone Propionate Akorn ANDA Current 50436-9992 Fluticasone Propionate Fluticasone Propionate Unit Dose Services ANDA Current 53002-7690 Fluticasone Propionate Fluticasone Propionate RPK Pharmaceuticals, Inc. ANDA Current 53002-7690 Fluticasone Propionate Fluticasone Propionate RPK Pharmaceuticals, Inc. ANDA Current 53002-7692 Fluticasone Propionate Fluticasone Propionate RPK Pharmaceuticals, Inc. ANDA Current 61919-620 FLUTICASONE FLUTICASONE Direct RX ANDA Current 63187-021 Fluticasone Propionate Fluticasone Propionate Proficient Rx LP ANDA Current 63187-021 Fluticasone Propionate Fluticasone Propionate Proficient Rx LP ANDA Current 63187-021 Fluticasone Propionate Fluticasone Propionate Proficient Rx LP ANDA Current 68071-4156 Fluticasone Propionate Fluticasone Propionate NuCare Pharmaceuticals,Inc. ANDA Current 68071-4156 Fluticasone Propionate Fluticasone Propionate NuCare Pharmaceuticals,Inc. ANDA Current 68788-9925 Fluticasone Propionate Fluticasone Propionate Preferred Pharmaceuticals, Inc. ANDA Current 68788-9925 Fluticasone Propionate Fluticasone Propionate Preferred Pharmaceuticals, Inc. ANDA Current 68788-9925 Fluticasone Propionate Fluticasone Propionate Preferred Pharmaceuticals, Inc. ANDA Current 68788-9925 Fluticasone Propionate Fluticasone Propionate Preferred Pharmaceuticals, Inc. ANDA Current 69306-016 Fluticasone Propionate Fluticasone Propionate Doc Rx ANDA Current 69306-016 Fluticasone Propionate Fluticasone Propionate Doc Rx ANDA Current 69306-016 Fluticasone Propionate Fluticasone Propionate Doc Rx ANDA Current 70518-0137 Fluticasone Propionate Fluticasone Propionate REMEDYREPACK INC. ANDA Current 76420-106 Fluticasone Propionate Fluticasone Propionate Asclemed USA, Inc. ANDA Current 76420-106 Fluticasone Propionate Fluticasone Propionate Asclemed USA, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43127 ORIG 2012-05-09 44357 ORIG 2008-01-30