Orange Book product · Brand (NDA)
CORTIFOAM
HYDROCORTISONE ACETATE
At a glance
Feb 10, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 10, 1982
45 yr ago
Today
Pharmaceutical detail
Active ingredient
HYDROCORTISONE ACETATE
Strength
10%
Dosage form
AEROSOL, METERED
Route
RECTAL
TE code
Not listed
Application
NDA 017351
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- —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
- —CORTEF ACETATEBrand (NDA)
NDA 008917 · PHARMACIA AND UPJOHN
- 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.
