Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074736
Company: WATSON LABS
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/21/1997 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
10/10/2019 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-33 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/15/2018 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

03/23/2004 SUPPL-8 Labeling

Label is not available on this site.

02/20/2004 SUPPL-7 Labeling

Label is not available on this site.

04/12/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

03/22/1999 SUPPL-3 Manufacturing (CMC)

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

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