Orange Book product · Brand (NDA)
CORTENEMA
HYDROCORTISONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDROCORTISONE
Strength
100MG/60ML
Dosage form
ENEMA
Route
RECTAL
TE code
AB
Application
NDA 016199
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.
- —CORT-DOMEBrand (NDA)
NDA 009585 · BAYER PHARMS
- 2018HYDROCORTISONEGeneric (ANDA)
ANDA 203810 · ENCUBE
- 2016ALA-CORTGeneric (ANDA)
ANDA 080706 · CROWN LABS
- 2010HYDROCORTISONEGeneric (ANDA)
ANDA 040879 · RISING
- 2004HYDROCORTISONEGeneric (ANDA)
ANDA 040503 · CHARTWELL MOLECULAR
- 1989HYDROCORTISONEGeneric (ANDA)
ANDA 089273 · TOPIDERM
- 1989HYDROCORTISONEGeneric (ANDA)
ANDA 089754 · ALPHARMA US PHARMS
- 1988NOGENIC HCGeneric (ANDA)
ANDA 087427 · IVAX PHARMS
- 1988HYDROCORTISONEGeneric (ANDA)
ANDA 089682 · ACTAVIS MID ATLANTIC
- 1988HYDROCORTISONEGeneric (ANDA)
ANDA 089706 · NASKA
- 1986HYDROCORTISONEGeneric (ANDA)
ANDA 089414 · FOUGERA PHARMS INC
- 1986HYDROCORTISONEGeneric (ANDA)
ANDA 089413 · PHARMADERM
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.
