Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090494
Company: SUN PHARM

Products on ANDA 090494

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 090494

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090494Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2022	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/21/2019	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/02/2019	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/02/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/02/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/02/2019	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/02/2019	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/23/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/23/2015	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.