FDA Orange Book · active-ingredient family
Hydrocortisone valerate
Hydrocortisone valerate: 2 brands, 11 generics; first approved Aug 08, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
11
Listed patents
0
Presentations
13
Brand (NDA) products
Originator applications
- WESTCORTRLDSUN PHARM INDS INCNDA 0187261983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% OINTMENT TOPICAL Discontinued — - WESTCORTRLDSUN PHARM INDS INCNDA 017950—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% CREAM TOPICAL Discontinued —
Generic (ANDA) products (11)
Abbreviated applications
- HYDROCORTISONE VALERATEENCUBE ETHICALSANDA 2110472021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% CREAM TOPICAL Rx AB - HYDROCORTISONE VALERATECOSETTE PHARMS NCANDA 2137242021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% CREAM TOPICAL Rx AB - HYDROCORTISONE VALERATECOSETTE PHARMS NCANDA 2117642020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% OINTMENT TOPICAL Rx AB - HYDROCORTISONE VALERATELUPINANDA 2103072019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% CREAM TOPICAL Rx AB - HYDROCORTISONE VALERATEGLENMARK PHARMS LTDANDA 2117502018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% OINTMENT TOPICAL Discontinued — - HYDROCORTISONE VALERATEGLENMARK PHARMS LTDANDA 2111292018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% CREAM TOPICAL Discontinued — - HYDROCORTISONE VALERATEFOUGERA PHARMSANDA 0750852001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% OINTMENT TOPICAL Discontinued — - HYDROCORTISONE VALERATEPADAGIS ISRAELANDA 0756662000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% CREAM TOPICAL Discontinued — - HYDROCORTISONE VALERATERSSUN PHARMA CANADAANDA 0750421998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% CREAM TOPICAL Rx AB - HYDROCORTISONE VALERATERSSUN PHARMA CANADAANDA 0750431998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% OINTMENT TOPICAL Rx AB - HYDROCORTISONE VALERATECOSETTE PHARMS NCANDA 0744891998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2% CREAM TOPICAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
43 yr 10 mo ago
Most recent approval
5 yr ago
Approvals span 1983–2021 across 13 FDA applications.
Brand (NDA) 215%
Generic (ANDA) 1185%
Hydrocortisone valerate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
