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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074918
Company: BARR

Products on ANDA 074918

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074918

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/1998	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74918ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74918.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/02/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
11/20/2002	SUPPL-12	Labeling		Label is not available on this site.
04/19/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
01/29/2001	SUPPL-8	Labeling		Label is not available on this site.
09/14/2000	SUPPL-7	Labeling		Label is not available on this site.
12/21/1999	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
11/22/1999	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
11/22/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/20/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/22/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074918

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

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