Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205302
Company: STRIDES ARCOLAB LTD

Products on ANDA 205302

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RILPIVIRINE	RILPIVIRINE	25MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205302

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2015	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205302Orig1s000TALtr_corrected.pdf