Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212606
Company: SHILPA MEDICARE

Products on ANDA 212606

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIRFENIDONE	PIRFENIDONE	UNKNOWN	UNKNOWN	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212606

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2020	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212606Orig1s000TAltr.pdf