Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209944
Company: SUNSHINE LAKE

Products on ANDA 209944

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APIXABAN	APIXABAN	2.GMG	TABLET;ORAL	None (Tentative Approval)	None	No	No
APIXABAN	APIXABAN	5MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209944

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2019	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209944Orig1s000TAltr.pdf