• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Tentative Approvals - December 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-345SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  PUREPAC PHARMACEUTICAL COMPANY12/6/2005 
276-748ROSIGLITAZONE MALEATE TABLETS, 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE)  DR. REDDY'S LABORATORIES LIMITED12/7/2005 
377-129RIVASTIGMINE TARTRATE CAPSULES, 1.5 MG (BASE), 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE)  WATSON LABORATORIES, INC.12/7/2005 
477-376MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, 45 MG  AUROBINDO PHARMA LIMITED12/8/2005 
576-798PIOGLITAZONE HYDROCHLORIDE TABLETS, 15 MG (BASE), 30 MG (BASE), AND 45 MG (BASE)  WATSON LABORATORIES, INC.12/13/2005 
677-136TERBINAFINE HYDROCHLORIDE TABLETS, 250 MG (BASE)  GENPHARM INC.12/13/2005 
776-596MODAFINIL TABLETS, 100 MG AND 200 MG  TEVA PHARMACEUTICALS USA12/16/2005 
877-299SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  PLIVA HRVATSKA D.O.O.12/21/2005 
977-363RIVASTIGMINE TARTRATE ORAL SOLUTION, 2 MG (BASE)/ML  RANBAXY INC.12/21/2005 
1077-774STAVUDINE FOR ORAL SOLUTION USP, 1 MG/ML  AUROBINDO PHARMA LIMITED12/21/2005 
1176-442SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  DR. REDDY'S LABORATORIES LIMITED12/27/2005 
1277-221LAMIVUDINE TABLETS, 150 MG AND 300 MG  WATSON LABORATORIES, INC.12/27/2005 
1377-378CARVEDILOL TABLETS, 3.125 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.12/27/2005 
1477-702NEVIRAPINE ORAL SUSPENSION, 50 MG/5 ML  AUROBINDO PHARMA LIMITED12/29/2005 
1577-335FINASTERIDE TABLETS USP, 1 MG  WATSON LABORATORIES, INC.12/29/2005 
1676-532SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG  TEVA PHARMACEUTICALS USA12/30/2005