Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com