Home Applications 040425 Application 040425
Type ANDA
Sponsor BARR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE TABLET;ORAL 0.1MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A040425-001 FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL 2003-01-21
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL 2003-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040425-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2003-01-21 cb3db0bc1861…
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 · 16 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fludrocortisone Acetate FLUDROCORTISONE ACETATE Major Pharmaceuticals 933e28ef-05e8-419e-a786-21eab67f33a2 2026-06-24 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE Cardinal Health 107, LLC 89b5687a-6e21-47cd-9c05-d9c9f4f8cf49 2026-05-15 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE fludrocortisone acetate FLUDROCORTISONE ACETATE Eywa Pharma Inc eff2eae8-94ce-46ca-a027-6b1d08e7b96b 2026-05-13 Warnings, Adverse reactions Name fallback brand name: fludrocortisone acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE Cardinal Health 107, LLC 3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da7 2026-05-06 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE NCS HealthCare of KY, LLC dba Vangard Labs 3c007f9a-4cd5-4e74-a633-d55dde1fe903 2026-02-27 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE AvKARE b8ce5b7e-7aa2-45f8-e053-2995a90a6c65 2026-01-15 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE AvPAK 2cd3965d-cab9-a97c-db61-7d03ced154f3 2026-01-08 Warnings, Adverse reactions Name fallback brand name: FLUDROCORTISONE ACETATE generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE Amneal Pharmaceuticals of New York LLC 4ed382df-f2d5-46a4-a68b-aba807777093 2025-12-20 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone acetate FLUDROCORTISONE ACETATE Golden State Medical Supply, Inc. 3752ff25-8887-5c88-e063-6294a90a345a 2025-08-29 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE American Health Packaging 001e72ea-2c9e-468c-90cc-6c347234e2a9 2025-05-19 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone acetate FLUDROCORTISONE ACETATE Zydus Lifesciences Limited 6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e 2024-10-29 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE Bryant Ranch Prepack 3d6f1a89-ea11-474d-aaca-64fea02a3beb 2024-07-30 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone acetate FLUDROCORTISONE ACETATE Viona Pharmaceuticals Inc bc92f5c6-3a65-4fab-85b3-fd5b84f917c1 2024-07-13 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE Amneal Pharmaceuticals NY LLC 51363453-6d33-4aee-8426-37ac0bf3cc10 2024-02-09 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE NorthStar Rx LLC 04ad6ba3-6781-b5df-e063-6294a90a7e6e 2023-09-07 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE Fludrocortisone Acetate FLUDROCORTISONE ACETATE Novitium Pharma LLC 96dbbf53-962b-49a4-a60d-91ae0b9fb9ff 2022-06-03 Warnings, Adverse reactions Name fallback brand name: Fludrocortisone Acetate generic name: FLUDROCORTISONE ACETATE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0555-0997 Fludrocortisone Acetate Fludrocortisone Acetate Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0997 Fludrocortisone Acetate Fludrocortisone Acetate Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0997 Fludrocortisone Acetate Fludrocortisone Acetate Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0997 Fludrocortisone Acetate Fludrocortisone Acetate Teva Pharmaceuticals USA, Inc. ANDA Current 43063-714 Fludrocortisone Acetate Fludrocortisone Acetate PD-Rx Pharmaceuticals, Inc. ANDA Current 63629-7780 Fludrocortisone Acetate Fludrocortisone Acetate Bryant Ranch Prepack ANDA Current 63629-7780 Fludrocortisone Acetate Fludrocortisone Acetate Bryant Ranch Prepack ANDA Current 63629-8806 Fludrocortisone Acetate Fludrocortisone Acetate Bryant Ranch Prepack ANDA Current 63629-8806 Fludrocortisone Acetate Fludrocortisone Acetate Bryant Ranch Prepack ANDA Current