Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203843
Company: WEST WARD PHARM CORP

Products on ANDA 203843

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203843

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2019	ORIG-1	Tentative Approval				Label is not available on this site.