Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074631
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/13/1998 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
02/18/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/28/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/2002 SUPPL-4 Labeling

Label is not available on this site.

01/28/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

BROMOCRIPTINE MESYLATE

TABLET;ORAL; EQ 2.5MG 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 2.5MG BASE TABLET;ORAL Prescription No AB 076962 MYLAN
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077646 PADDOCK LLC
BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 074631 SANDOZ INC
PARLODEL BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription Yes AB 017962 US PHARMS HOLDINGS I

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