Orange Book product · Brand (NDA)
DOSTINEX
CABERGOLINE
At a glance
Dec 23, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CABERGOLINE
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020664
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.
- 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
- 2008CABERGOLINEGeneric (ANDA)
ANDA 078035 · ACTAVIS LABS FL INC
- 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.
