Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077226
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/04/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/21/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/13/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/15/2006 SUPPL-1 Labeling

Label is not available on this site.

BROMOCRIPTINE MESYLATE

CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 077226 MYLAN
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 078899 ZYDUS PHARMS USA INC
PARLODEL BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription Yes AB 017962 US PHARMS HOLDINGS I

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