Orange Book product · Brand (NDA)
PARLODEL
BROMOCRIPTINE MESYLATE
At a glance
Mar 01, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 01, 1982
44 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BROMOCRIPTINE MESYLATE
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 017962
Product number
002
Marketing status
RX
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.
- 2009CYCLOSETBrand (NDA)
NDA 020866 · VEROSCIENCE
- 2008BROMOCRIPTINE MESYLATEGeneric (ANDA)
ANDA 077646 · PADAGIS US
- 2008BROMOCRIPTINE MESYLATEGeneric (ANDA)
ANDA 078899 · ZYDUS PHARMS USA INC
- 2005BROMOCRIPTINE MESYLATEGeneric (ANDA)
ANDA 077226 · MYLAN
- 2004BROMOCRIPTINE MESYLATEGeneric (ANDA)
ANDA 076962 · AUROBINDO PHARMA USA
- 1998BROMOCRIPTINE MESYLATEGeneric (ANDA)
ANDA 075100 · LEK PHARM
- 1998BROMOCRIPTINE MESYLATEGeneric (ANDA)
ANDA 074631 · SANDOZ
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.
