Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214183
Company: SHANGHAI DESANO BIO-PHARMA CO LTD

Products on ANDA 214183

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2023	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.