Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208043
Company: ACTAVIS LABS FL INC

Products on ANDA 208043

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE	8MG/90MG	TABLET, EXTENDED RELEASE; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208043

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2022	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208043Orig1s000TAltr.pdf