Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210814
Company: SUN PHARM INDS LTD

Products on ANDA 210814

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210814

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2020	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210814Orig1s000TAltr.pdf