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FDA Approval Activities for this Drug…
Narcan (naloxone hydrochloride) Injection USP, Endo NDA 16-636/S-052, S-054 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 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Tablet; Sublingual 2MG;0.5MG SUBOXONE RECKITT BENCKISER 020733 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Tablet; Sublingual 8MG;2MG SUBOXONE RECKITT BENCKISER 070171 NALOXONE HYDROCHLORIDE Injection 0.02MG/ML NALOXONE HCL Abbott 070252 NALOXONE HYDROCHLORIDE Injection 0.02MG/ML NALOXONE HCL Abbott 070253 NALOXONE HYDROCHLORIDE Injection 0.02MG/ML NALOXONE HCL Abbott 070254 NALOXONE HYDROCHLORIDE Injection 0.4MG/ML NALOXONE HCL Abbott 070255 NALOXONE HYDROCHLORIDE Injection 0.4MG/ML NALOXONE HCL Abbott 070256 NALOXONE HYDROCHLORIDE Injection 0.4MG/ML NALOXONE HCL Abbott 070257 NALOXONE HYDROCHLORIDE Injection 0.4MG/ML NALOXONE HCL Abbott 016636 NALOXONE HYDROCHLORIDE Injection 0.02MG/ML NARCAN ENDO 016636 NALOXONE HYDROCHLORIDE Injection 0.4MG/ML NARCAN ENDO 016636 NALOXONE HYDROCHLORIDE Injection 1MG/ML NARCAN ENDO 070639 NALOXONE HYDROCHLORIDE Injection 0.4MG/ML NALOXONE HCL INTL MEDICATION 072076 NALOXONE HYDROCHLORIDE Injection 1MG/ML NALOXONE HCL INTL MEDICATION 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 | Subutex (buprenorphine HCl), Reckitt Benckiser, Labeling Revision | Suboxone (buprenorphine HCl and naloxone HCl), Reckitt Benckiser, Labeling Revision | Naloxone Hydrochloride Injection, International Medication Systems, Ltd., Facility Addition | Talwin NX (naloxone hydrochloride and pentazocine hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision | Suboxone (buprenorphine and naloxone) Film Oral, Reckitt Benckiser Pharmaceuticals Inc., Approval | Suboxone (buprenorphine and naloxone) Oral Soluble Film, Reckitt Benckiser Pharmaceuticals Inc., Labeling Revision | Talwin Nx (naloxone hydrochloride and pentazocine hydrochloride) Tablets, Sanofi-Vventis U.S. LLC, Labeling Revision
  
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