Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 210865
Company: MYLAN LABS LTD

Products on NDA 210865

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOLUTEGAVIR; LAMIVUDINE; TENOFOVIR ALAFENAMIDE FUMARATE	DOLUTEGAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE FUMARATE	UNKNOWN	UNKNOWN	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210865

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2019	ORIG-1	Tentative Approval	Type 4 - New Combination	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210865Orig1s000TA_ltr.pdf