Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214521
Company: MYLAN LABS LTD

Products on NDA 214521

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2020	ORIG-1	Tentative Approval	Type 3 - New Dosage Form	PRIORITY	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214521Orig1s000TAltr.pdf