Home Applications 075042 Application 075042
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE CREAM;TOPICAL 0.2% No Yes
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 A075042-001 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075042-001 AB
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 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0713-0668 Hydrocortisone Valerate Hydrocortisone Valerate G&W Laboratories, Inc. ANDA Current 0713-0668 Hydrocortisone Valerate Hydrocortisone Valerate Cosette Pharmaceuticals, Inc. ANDA Current 0713-0668 Hydrocortisone Valerate Hydrocortisone Valerate Cosette Pharmaceuticals, Inc. ANDA Current 21695-730 Hydrocortisone Valerate Hydrocortisone Valerate Rebel Distributors Corp ANDA Current 51672-1290 Hydrocortisone Valerate Hydrocortisone Valerate Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-1290 Hydrocortisone Valerate Hydrocortisone Valerate Taro Pharmaceuticals U.S.A., Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39452 ORIG 2004-06-07 22405 ORIG 2003-08-05 30738 ORIG 1998-08-25