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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213120
Company: LUPIN LTD

Products on ANDA 213120

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213120

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/13/2023	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213120Orig1s000TAltr.pdf

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