Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215448
Company: AUROBINDO PHARMA USA

Products on NDA 215448

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE	DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE	50MG/200MG/25MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215448

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/2023	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/2023/215448Orig1s000TAltr.pdf