Home Applications 080828 Application 080828
Type ANDA
Sponsor FERA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE OINTMENT;OPHTHALMIC 0.5% 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 A080828-001 HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982
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 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080828-001 HYDROCORTISONE ACETATE 0.5% OINTMENT / OPHTHALMIC Approved before 1982 cb3db0bc1861…
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 · 41 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join procure HYDROCORTISONE ACETATE TWIN MED, LLC 2670c9c4-66ad-40e8-a08a-582b160de39d 2026-08-03 Warnings Name fallback generic name: HYDROCORTISONE ACETATE Hydrocortisone Acetate HYDROCORTISONE ACETATE AARNA USA INC. 4f9709ed-4818-3d3b-e063-6394a90a0d04 2026-04-16 Adverse reactions Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE Hydrocortisone Acetate HYDROCORTISONE ACETATE AvPAK d13b0bea-4c7b-4ee4-aab1-aca8cdcea7fd 2026-01-08 Adverse reactions Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE American Safety and First Aid HYDROCORTISONE ACETATE Orazen Inc 4a543f90-d43c-4487-b27e-f43394c6320d 2026-01-04 Warnings Name fallback generic name: HYDROCORTISONE ACETATE Hemmorex-HC HYDROCORTISONE ACETATE Laser Pharmaceuticals, LLC d625764a-6171-4802-9bc0-95e5785b8b7d 2026-01-01 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE ACETATE MEDI FIRST PLUS HYDROCORTISONE ACETATE Orazen Inc 5781124a-60f4-4a64-80b7-ce5f28d495b5 2025-12-12 Warnings Name fallback generic name: HYDROCORTISONE ACETATE MEDI-FIRST HYDROCORTISONE ACETATE Orazen Inc aeffd85c-58a7-4d64-bf94-977b6fbbe713 2025-12-12 Warnings Name fallback generic name: HYDROCORTISONE ACETATE Hydrocortisone Acetate Antipruritic (Anti-Itch) HYDROCORTISONE ACETATE Sun Pharmaceutical Industries, Inc. 9f0b09e7-6cfd-4fd6-8631-67799edf4e08 2025-12-02 Warnings Name fallback generic name: HYDROCORTISONE ACETATE Hydrocortisone Acetate HYDROCORTISONE ACETATE Marlex Pharmaceuticals, Inc. e60473f7-fd00-a477-e053-2a95a90ad4dd 2025-11-13 Adverse reactions Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE Hydrocortisone Acetate HYDROCORTISONE ACETATE Major Pharmaceuticals 1281a82d-df00-4421-9c0d-951f8f9a9422 2025-08-05 Adverse reactions Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE Hydrocortisone HYDROCORTISONE ACETATE Rite Aid Corporation cb6e0bed-2ea1-49d2-89e7-2554e7565b74 2025-07-11 Warnings Name fallback generic name: HYDROCORTISONE ACETATE Hydrocortisone HYDROCORTISONE ACETATE Walgreen Company bff322f1-59c3-41e0-8685-fcfe52bf4b42 2025-07-10 Warnings Name fallback generic name: HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE Golden State Medical Supply, Inc. fe42cde7-b3ac-2014-e053-6394a90a0f67 2025-02-24 Adverse reactions Name fallback brand name: HYDROCORTISONE ACETATE generic name: HYDROCORTISONE ACETATE Hemmorex-HC HYDROCORTISONE ACETATE Laser Pharmaceuticals, LLC db67f724-c78c-4280-9c2e-6abbaeaef42d 2025-01-23 Adverse reactions Name fallback generic name: HYDROCORTISONE ACETATE Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula HYDROCORTISONE ACETATE Combe Incorporated 9b69fa24-02dd-43e4-a81f-9a37968d7099 2024-12-12 Warnings Name fallback generic name: HYDROCORTISONE ACETATE Hydrocortisone Acetate HYDROCORTISONE ACETATE Westminster Pharmaceuticals, LLC 3a29006f-9124-45e7-84a2-48f08bbb5f9c 2024-12-04 Adverse reactions Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE Proctocort HYDROCORTISONE ACETATE Salix Pharmaceuticals, Inc a2e1222a-ab91-4382-a210-7dfdd6de1407 2024-09-17 Adverse reactions Name fallback generic name: HYDROCORTISONE ACETATE Anti-Itch Vulva Cream 1 Hydrocortisone Acetate HYDROCORTISONE ACETATE The Honey Pot Company LLC 6f32b536-6ebf-49a8-abb6-2a1daae2f6d7 2024-08-01 Warnings Name fallback generic name: HYDROCORTISONE ACETATE Hydrocortisone Acetate HYDROCORTISONE ACETATE NuCare Pharmaceuticals,Inc. af1142eb-553e-7686-e053-2a95a90a0f9a 2024-07-17 Adverse reactions Name fallback brand name: Hydrocortisone Acetate generic name: HYDROCORTISONE ACETATE Anusol HC HYDROCORTISONE ACETATE Salix Pharmaceuticals, Inc a562f3d7-2692-4357-aade-ae50afcbfddd 2024-07-01 Adverse reactions Name fallback generic name: HYDROCORTISONE ACETATE