Home Applications 211764 Application 211764
Type ANDA
Sponsor COSETTE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE OINTMENT;TOPICAL 0.2% 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 A211764-001 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211764-001 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.
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 2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 cb3db0bc1861…2026-08-01 22:54:32 2026-06 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0713-0560 Hydrocortisone Valerate HYDROCORTISONE VALERATE Cosette Pharmaceuticals, Inc. ANDA Current 0713-0560 Hydrocortisone Valerate HYDROCORTISONE VALERATE Cosette Pharmaceuticals, Inc. ANDA Current 0713-0560 Hydrocortisone Valerate HYDROCORTISONE VALERATE Cosette Pharmaceuticals, Inc. ANDA Current