Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216543
Company: HETERO LABS LTD III

Products on ANDA 216543

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOLUTEGRAVIR; LAMIVUDINE	DOLUTEGRAVIR;LAMIVUDINE	50MG;300MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216543

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/2024	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.