Orange Book product · Generic (ANDA)
HYDROCORTISONE VALERATE
HYDROCORTISONE VALERATE
At a glance
Mar 04, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 04, 2020
6 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCORTISONE VALERATE
Strength
0.2%
Dosage form
OINTMENT
Route
TOPICAL
TE code
AB
Application
ANDA 211764
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCORTISONE VALERATE
- 1983WESTCORTBrand (NDA)
NDA 018726 · SUN PHARM INDS INC
- —WESTCORTBrand (NDA)
NDA 017950 · SUN PHARM INDS INC
- 2021HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 211047 · ENCUBE ETHICALS
- 2021HYDROCORTISONE VALERATEGeneric (ANDA)
ANDA 213724 · 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.
