Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201686
Company: ZYDUS LIFESCIENCES

Products on ANDA 201686

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201686

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2019	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/01/2019	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/01/2019	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.