Drugs@FDA: FDA Approved Drug Products

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

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 207905 APOTEX
NALTREXONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 074918 BARR
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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