Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076264
Company: SPECGX LLC

Products on ANDA 076264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	None	No	No
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AB	No	Yes
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2002	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76264.APD.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076264_S000_ORIGINAL APPROVAL_PACKAGE.pdf

Therapeutic Equivalents for ANDA 076264

NALTREXONE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	091205	ACCORD HLTHCARE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	074918	BARR
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	207905	CHARTWELL
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	075274	ELITE LABS
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	076264	SPECGX LLC
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	090356	SUN PHARM