Orange Book product · Generic (ANDA)
CABERGOLINE
CABERGOLINE
At a glance
Apr 21, 2008
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 21, 2008
18 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CABERGOLINE
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 078035
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CABERGOLINE
- 1996DOSTINEXBrand (NDA)
NDA 020664 · PFIZER
- 2024CABERGOLINEGeneric (ANDA)
ANDA 218109 · SOMERSET THERAPS LLC
- 2024CABERGOLINEGeneric (ANDA)
ANDA 218618 · AMNEAL
- 2018CABERGOLINEGeneric (ANDA)
ANDA 204735 · INGENUS PHARMS LLC
- 2013CABERGOLINEGeneric (ANDA)
ANDA 202947 · PHARMOBEDIENT
- 2013CABERGOLINEGeneric (ANDA)
ANDA 201503 · APOTEX CORP
- 2007CABERGOLINEGeneric (ANDA)
ANDA 077843 · IMPAX LABS INC
- 2007CABERGOLINEGeneric (ANDA)
ANDA 077750 · IVAX SUB TEVA PHARMS
- 2005CABERGOLINEGeneric (ANDA)
ANDA 076310 · STRIDES PHARMA INTL
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.
