Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078899
Company: ZYDUS PHARMS USA INC

Products on ANDA 078899

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078899

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2008	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-8	Labeling-Package Insert		Label is not available on this site.
01/19/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/13/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078899

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