Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077226
Company: MYLAN

Products on ANDA 077226

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077226

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.

Therapeutic Equivalents for ANDA 077226

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	SS PHARMA