Orange Book product · Brand (NDA)
WESTCORT
HYDROCORTISONE VALERATE
At a glance
Aug 08, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 08, 1983
43 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCORTISONE VALERATE
Strength
0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
OINTMENT
Route
TOPICAL
TE code
Not listed
Application
NDA 018726
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —WESTCORTBrand (NDA)
NDA 017950 · SUN PHARM INDS INC
- 2021HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211047 · ENCUBE ETHICALS
- 2021HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 213724 · COSETTE PHARMS NC
- 2020HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211764 · COSETTE PHARMS NC
- 2019HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 210307 · LUPIN
- 2018HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211750 · GLENMARK PHARMS LTD
- 2018HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211129 · GLENMARK PHARMS LTD
- 2001HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 075085 · FOUGERA PHARMS
- 2000HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 075666 · PADAGIS ISRAEL
- 1998HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 075042 · SUN PHARMA CANADA
- 1998HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 075043 · SUN PHARMA CANADA
- 1998HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 074489 · COSETTE
Listed patents
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.
