Drugs

First-Time Generic Drug Approvals - February 2013

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION USP, 2 MG/ML; PACKAGED IN 20 MG/10 ML AND 50 MG/25 ML SINGLE-USE VIALS     SUN PHARMA GLOBAL FZE DOXIL LIPOSOME INJECTION 2/4/2013 
2 MAFENIDE ACETATE, USP FOR 5% TOPICAL SOLUTION, 50 G STERILE POWDER PER PACKET        PAR FORMULATIONS PRIVATE LIMITED SULFAMYLON FOR 5% TOPICAL SOLUTION 2/12/2013 
3 FLUDEOXYGLUCOSE F 18 INJECTION USP, 20-500 mCi/mL @ EOS        HOUSTON CYCLOTRON PARTNERS LP FLUDEOXYGLUCOSE F18 INJECTION, USP 2/14/2013 
4 BUPRENORPHINE HCl AND NALOXONE HCl DIHYDRATE SUBLINGUAL TABLETS, 2 MG (BASE)/0.5 MG (BASE) AND 8 MG (BASE)/2 MG (BASE)      AMNEAL PHARMACEUTICALS SUBOXONE SUBLINGUAL TABLETS 2/22/2013 
5 BUPRENORPHINE HCl AND NALOXONE HCL DIHYDRATE SUBLINGUAL TABLETS, 2 MG (BASE)/0.5 MG (BASE) AND 8 MG (BASE)/2 MG (BASE)      ACTAVIS ELIZABETH LLC SUBOXONE TABLETS (SUBLINGUAL) 2/22/2013 
6 ALENDRONATE SODIUM ORAL SOLUTION, 70 MG (BASE)/75 ML (ONCE WEEKLY)       ROXANE LABORATORIES, INC. FOSAMAX ORAL SOLUTION 2/25/2013 
7 DEXBROMPHENIRAMINE MALEATE & PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS, (OTC), 6 MG/120 MG       AVANTHI INC. DRIXORAL COLD AND ALLERGY TABLETS 2/27/2013 

 

Page Last Updated: 03/10/2016
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