Home Applications 080438 Application 080438
Type ANDA
Sponsor BAYER PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HC #1 HYDROCORTISONE CREAM;TOPICAL 0.5% No No 002 HC #4 HYDROCORTISONE CREAM;TOPICAL 1% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080438-001 HC #1 HYDROCORTISONE 0.5% CREAM / TOPICAL Approved before 1982 A080438-002 HC #4 HYDROCORTISONE 1% CREAM / TOPICAL 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 3 · 82 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 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080438-001 HC #1 0.5% CREAM / TOPICAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A080438-002 HC #4 1% CREAM / TOPICAL Approved before 1982 782e0a99824c…
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 3 of 19 · 369 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alkindi Sprinkle HYDROCORTISONE Eton Pharmaceuticals, Inc. 26c13a5f-7119-4c6a-bf10-fda4e07d7682 2026-04-21 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Anti-Itch Regular Strength HYDROCORTISONE CVS Pharmacy 9fe7768b-9023-c9ee-e053-2a95a90a55b3 2026-04-17 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 2352bb58-a624-4c5e-8966-f68817c30470 2026-04-03 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 9f64ed9d-64c8-48e9-ac54-1aa9b26a6060 2026-04-03 Adverse reactions Name fallback generic name: HYDROCORTISONE FifthPulse Hydrocortisone HYDROCORTISONE WeCare Products LLC f1fcb045-4a15-431b-9617-67eae9f87fbd 2026-04-02 Warnings Name fallback generic name: HYDROCORTISONE Hydroxym HYDROCORTISONE Oncora Pharma, LLC a161b69c-df9d-4827-ace8-f622aca9efc3 2026-04-02 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Khindivi HYDROCORTISONE Eton Pharmaceuticals, Inc. 1ef80500-8386-40ee-b608-516cd687b376 2026-04-01 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Redmont Pharmaceuticals, LLC fb2f9fa2-5feb-4398-a21b-15a3137ac3bd 2026-03-31 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 5e95eb82-40cd-411b-9006-c27b65db4b3f 2026-03-25 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 7f262fa3-4d2a-43f2-a4a7-f49f6034cf50 2026-03-25 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 3d17e73a-15f5-4881-baf2-47a0149585fd 2026-03-25 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone 1% HYDROCORTISONE ProStat First Aid 4e53d29c-ed3c-f481-e063-6294a90a3181 2026-03-25 Warnings Name fallback generic name: HYDROCORTISONE BARMICIL PLUS HYDROCORTISONE OPMX LLC fb5f4743-61e8-46c8-8561-38e17aeaa4d5 2026-03-24 Warnings Name fallback generic name: HYDROCORTISONE Barmicil Anti-itch HYDROCORTISONE OPMX LLC 850084c3-1dd4-eb8d-e053-2a91aa0a130b 2026-03-24 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 99726aa3-3b45-4175-8471-279419af5457 2026-03-18 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Mericon Industries 8f351b04-8f6d-4353-9100-13a8a80d656a 2026-03-17 Warnings Name fallback generic name: HYDROCORTISONE Crane Safety Hydrocortisone HYDROCORTISONE Crane Safety LLC 96d9527d-9bf7-ce82-e053-2995a90aff0c 2026-03-16 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone 1% HYDROCORTISONE ProStat First Aid 4cd62cba-075a-7448-e063-6394a90ab48d 2026-03-12 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Strides Pharma Science Limited 90a46849-5b75-467b-9bc5-8f192d4d20d2 2026-03-11 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE DIRECT RX 3d017594-3a00-40ba-b392-1699992fa1b1 2026-03-05 Adverse reactions Name fallback generic name: HYDROCORTISONE