Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077646
Company: PADAGIS US

Products on ANDA 077646

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077646

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/01/2008	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
04/27/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/21/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077646

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	077646	PADAGIS US
BROMOCRIPTINE MESYLATE	BROMOCRIPTINE MESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	074631	SANDOZ
PARLODEL	BROMOCRIPTINE MESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	017962	SS PHARMA