Drugs@FDA: FDA Approved Drug Products

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

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 PHARM

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