Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074631
Company: SANDOZ

Products on ANDA 074631

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074631

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
11/08/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
01/07/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 074631

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