Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219623
Company: EMCURE PHARMS LTD

Products on ANDA 219623

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219623

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.