U.S. Food and Drug Administration Center for Drug Evaluation and ResearchSkip navigation

CDER - Center for Drug Evaluation and Research Logo

Drug Information

CDER Home Site Information Comments and Feedback What's New CDER Navigation Bar
[FrontPage Include Component]

First-Time Generics - January 2003

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 STRONTIUM CHLORIDE Sr-89 INJECTION, USP 1 mCi/Ml BIO-NUCLEONICS PHARMA, INC. METASTRON INJECTION 1/6/03
2 LORATADINE TABLETS (OTC) 10 MG GENEVA PHARMACEUTICALS, INC. CLARITIN TABLETS 1/21/03
3 MIRTAZAPINE TABLETS 15 MG AND 30 MG TEVA PHARMACEUTICALS USA REMERON TABLETS 1/24/03
4 ETIDRONATE DISODIUM TABLETS, USP 200 MG AND 400 MG GENPHARM INC. DIDRONEL TABLETS 1/24/03
5 RILUZOLE TABLETS 50 MG IMPAX LABORATORIES, INC. RILUTEK TABLETS 1/29/03
6 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 5 MG/120 MG (12-HOUR FORMULATION) (OTC) IMPAX LABORATORIES CLARITIN-D 12-HOUR EXTENDED-RELEASE TABLETS 1/30/03
7 BUTALBITAL, ACETAMINOPHEN, & CAFFEINE ORAL SOLUTION 50 MG/325 MG/40 MG, RESPECTIVELY, PER 15 ML MIKART, INC. FIORICET TABLETS 1/31/03

totop.gif (1525 bytes) Back to Top   Back Back to Approvals

FDA/Center for Drug Evaluation and Research
Last Updated: January 2, 2003
Originator: OTCOM/OGD
HTML by SJW