Orange Book product · Brand (NDA)
CORTEF ACETATE
HYDROCORTISONE ACETATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDROCORTISONE ACETATE
Strength
2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 008917
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.
- 1982CORTIFOAMBrand (NDA)
NDA 017351 · VIATRIS
- —CORTEF ACETATEBrand (NDA)
NDA 009378 · PHARMACIA AND UPJOHN
- —CORTRILBrand (NDA)
NDA 009164 · PFIZER
- —HYDROCORTISONE ACETATEBrand (NDA)
NDA 009637 · EPIC PHARMA LLC
- —HYDROCORTONEBrand (NDA)
NDA 008228 · MERCK
- —HYDROCORTONEBrand (NDA)
NDA 009018 · MERCK
- 2002MICORT-HCGeneric (ANDA)
ANDA 040398 · LEGACY PHARMA
- 2001MICORT-HCGeneric (ANDA)
ANDA 040396 · LEGACY PHARMA
- 1999HYDROCORTISONE ACETATEGeneric (ANDA)
ANDA 040259 · IMPERIUM
- 1992HEMSOL-HCGeneric (ANDA)
ANDA 081274 · ABLE
- 1989HYDROCORTISONE ACETATEGeneric (ANDA)
ANDA 089914 · PARKE DAVIS
- 1988U-CORTGeneric (ANDA)
ANDA 089472 · SUN PHARMA CANADA
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.
