Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216223
Company: LAURUS LABS LTD

Products on ANDA 216223

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE	ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE	600MG;50MG;300MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216223

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2022	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.