Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075523
Company: SUN PHARM INDS LTD
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
03/17/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75523ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75523_Pentazocine_Naloxone.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-3 REMS - PROPOSAL - D-N-A

Label is not available on this site.

03/31/2017 SUPPL-2 Labeling-Medication Guide, 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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