Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207905
Company: APOTEX INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/21/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

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 INC
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 PHARMA GLOBAL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English