FDA Approval Activities for this Drug…

Pentazocine & Naloxone Hydrochloride Tablets, 50 mg (base) & 0.5 mg (base), Amide Pharmaceutical ANDA 75-735 7/11/01 Pentazocine & Naloxone Hydrochloride,50 mg (base) & 0.5 mg (base), Ranbaxy Limited ANDA 75-523 Pentazocine Hydrochloride & Acetaminophen, 25 mg (base)/650, Watson, ANDA 74-699 3/24/00 3/31/00 Pentazocine Hydrochloride & Acetaminophen Tablets, 25 mg (base)/650, Amide ANDA 76-202 Talacen (pentazocine HCl and acetaminophen) Caplets, Sanofi-Synthelabo NDA 18-458/S-012 7/10/03 7/28/03 Talwin NX (pentazocine HCl and naloxone HCl) Tablets, Sanofi-Synthelabo NDA 18-733/S-012 ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE Tablet; 650MG;EQ 25MG BASE ACETAMINOPHEN AND PENTAZOCINE HCL Amide 018458 ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE Tablet; 650MG;EQ 25MG BASE TALACEN SANOFI SYNTHELABO 074699 ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE Tablet; 650MG;EQ 25MG BASE PENTAZOCINE HCL AND ACETAMINOPHEN Watson 075735 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE Tablet; 0.5MG BASE;EQ 50MG BASE NALOXONE HCL AND PENTAZOCAINE Amide 075523 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE Tablet; 0.5MG BASE;EQ 50MG BASE PENTAZOCINE AND NALOXONE HYDROCHLORIDES Ranbaxy 018733 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE Tablet; 0.5MG BASE;EQ 50MG BASE TALWIN NX SANOFI SYNTHELABO 074736 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE Tablet; 0.5MG BASE;EQ 50MG BASE PENTAZOCINE AND NALOXONE HYDROCHLORIDES Watson 016194 PENTAZOCINE LACTATE Injection 30MG BASE/ML TALWIN Abbott Talwin (pentazocine Lactate Injection, USP), Hospira, Inc.

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