Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214566
Company: MACLEODS PHARMS LTD

Products on NDA 214566

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOLUTEGRAVIR SODIUM	DOLUTEGRAVIR SODIUM	10MG	TABLET; ORAL SUSPENSION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214566

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2021	ORIG-1	Tentative Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214566Orig1s000TA_ltr.pdf