Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075735
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE 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
07/11/2001 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2019 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/20/2018 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-13 REMS - PROPOSAL - D-N-A

Label is not available on this site.

04/20/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/20/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/07/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL; EQ 0.5MG BASE;EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE TABLET;ORAL Prescription No AB 075735 LUPIN
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE TABLET;ORAL Prescription No AB 075523 SUN PHARM INDS LTD
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE TABLET;ORAL Prescription No AB 074736 WATSON LABS

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