FDA Orange Book · active-ingredient family
Cabergoline
Cabergoline is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DOSTINEX · NDA 020664
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOSTINEXRLD | PFIZER | NDA 020664 | — | Dec 23, 1996 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CABERGOLINE | SOMERSET THERAPS LLC | ANDA 218109 | AB | Sep 09, 2024 | |
| CABERGOLINE | AMNEAL | ANDA 218618 | AB | Jun 26, 2024 | |
| CABERGOLINE | INGENUS PHARMS LLC | ANDA 204735 | AB | Aug 01, 2018 | |
| CABERGOLINE | PHARMOBEDIENT | ANDA 202947 | — | Dec 02, 2013 | |
| CABERGOLINE | APOTEX CORP | ANDA 201503 | — | Mar 08, 2013 | |
| CABERGOLINE | ACTAVIS LABS FL INC | ANDA 078035 | — | Apr 21, 2008 | |
| CABERGOLINE | IMPAX LABS INC | ANDA 077843 | — | Jul 03, 2007 | |
| CABERGOLINE | IVAX SUB TEVA PHARMS | ANDA 077750 | AB | Mar 07, 2007 | |
| CABERGOLINE | STRIDES PHARMA INTL | ANDA 076310 | AB | Dec 29, 2005 |
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.
Cabergoline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
