Orange Book product · Brand (NDA)
CORTONE
CORTISONE 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
CORTISONE ACETATE
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 007750
Product number
003
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.
- —CORTISONE ACETATEBrand (NDA)
NDA 008126 · PHARMACIA AND UPJOHN
- —CORTONEBrand (NDA)
NDA 007110 · MERCK
- —CORTISONE ACETATEBrand (NDA)
NDA 009458 · IMPAX LABS
- —CORTISONE ACETATEBrand (NDA)
NDA 008284 · PANRAY
- —CORTISONE ACETATEGeneric (ANDA)
ANDA 083147 · WATSON LABS
- —CORTISONE ACETATEGeneric (ANDA)
ANDA 085677 · WATSON LABS
- —CORTISONE ACETATEGeneric (ANDA)
ANDA 083471 · BARR
- —CORTISONE ACETATEGeneric (ANDA)
ANDA 080694 · CHARTWELL MOLECULAR
- —CORTISONE ACETATEGeneric (ANDA)
ANDA 080836 · ELKINS SINN
- —CORTISONE ACETATEGeneric (ANDA)
ANDA 084246 · EVERYLIFE
- —CORTISONE ACETATEGeneric (ANDA)
ANDA 085736 · HEATHER
- —CORTISONE ACETATEGeneric (ANDA)
ANDA 080776 · HIKMA INTL PHARMS
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.
