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

Drugs

  • Print
  • Share
  • E-mail

Approvals - November 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
177-070SOTALOL HYDROCHLORIDE TABLETS USP (AF), 80 MG, 120 MG, AND 160 MG  GENPHARM INC.11/4/2005 
277-310CILOSTAZOL TABLETS, 50 MG  SANDOZ INC.11/8/2005 
365-256AMOXICILLIN TABLETS USP, 500 MG AND 875 MG  AUROBINDO PHARMA LIMITED11/9/2005 
465-271AMOXICILLIN CAPSULES USP, 250 MG AND 500 MG  AUROBINDO PHARMA LIMITED11/9/2005 
577-293FUROSEMIDE TABLETS USP, 20 MG, 40 MG, AND 80 MG  EXCELLIUM PHARMACEUTICAL, INC.11/9/2005 
677-311HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 MG, 4 MG, AND 8 MG  KV PHARMACEUTICAL COMPANY11/9/2005 
777-394SODIUM BICARBONATE INJECTION USP, 7.5% (0.9 mEq/ML) AND 8.4% (1 mEq/ML) SYRINGES  HOSPIRA, INC.11/9/2005 
865-277DOXYCYCLINE HYCLATE TABLETS USP, 20 MG (BASE)  LANNETT HOLDINGS, INC.11/10/2005 
965-150AZITHROMYCIN TABLETS, 600 MG  TEVA PHARMACEUTICALS USA11/14/2005 
1065-153AZITHROMYCIN TABLETS, 250 MG  TEVA PHARMACEUTICALS USA11/14/2005 
1165-193AZITHROMYCIN TABLETS, 500 MG  TEVA PHARMACEUTICALS USA11/14/2005 
1265-209AZITHROMYCIN TABLETS, 600 MG  SANDOZ, INC.11/14/2005 
1365-211AZITHROMYCIN TABLETS, 250 MG  SANDOZ, INC.11/14/2005 
1465-212AZITHROMYCIN TABLETS, 500 MG  SANDOZ, INC.11/14/2005 
1565-218AZITHROMYCIN TABLETS, 600 MG  PLIVA HRVATSKA D.O.O.11/14/2005 
1665-223AZITHROMYCIN TABLETS, 500 MG  PLIVA HRVATSKA D.O.O.11/14/2005 
1765-225AZITHROMYCIN TABLETS, 250 MG  PLIVA HRVATSKA D.O.O.11/14/2005 
1865-235CEFPROZIL TABLETS USP, 250 MG AND 500 MG  SANDOZ INC.11/14/2005 
1977-601CITALOPRAM HYDROBROMIDE ORAL SOLUTION, 10 MG (BASE)/5 ML  APOTEX INC.11/15/2005 
2065-253CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG  AUROBINDO PHARMA LIMITED11/16/2005 
2140-596PROMETHAZINE HYDROCHLORIDE TABLETS USP, 12.5 MG, 25 MG, AND 50 MG  ZYDUS PHARMACEUTICALS USA, INC.11/18/2005 
2276-527OFLOXACIN OTIC SOLUTION, 0.3%  APOTEX INC.11/18/2005 
2375-959OCTREOTIDE ACETATE INJECTION, 0.2 MG(BASE)/ML AND 1 MG (BASE)/ML; 5 ML VIALS  SICOR PHARMACEUTICALS, INC.11/21/2005 
2477-127NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 30 MG AND 60 MG  OSMOTICA PHARMACEUTICAL CORPORATION11/21/2005 
2565-188AMPICILLIN AND SULBACTAM FOR INJECTION USP, 10 G(BASE)/5 G(BASE) PER VIAL; 15 G  G.C. HANFORD MANUFACTURING COMPANY11/25/2005 
2665-229CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG  LUPIN LIMITED11/25/2005 
2776-496METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG  BARR LABORATORIES, INC.11/25/2005 
2877-624GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG  MYLAN PHARMACEUTICALS, INC.11/28/2005 
2965-222AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1 G(BASE)/500 MG(BASE) PER VIAL, AND 2 G(BASE)/1 G(BASE) PER VIAL  INSTITUTO BIOCHIMICO ITALIANO, S.P.A.11/29/2005 
3076-434CHLORHEXIDINE GLUCONATE ORAL RINSE USP, 0.12%  JOHN O. BUTLER COMPANY11/29/2005 
3165-176AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1 G(BASE)/500 MG(BASE) PER VIAL & PIGGYBACK BOTTLE; 2 G(BASE)/1 G(BASE) PER VIAL & PIGGYBACK BOTTLE  G.C. HANFORD MANUFACTURING COMPANY11/30/2005 
3265-192MUPIROCIN OINTMENT USP, 2%  ALTANA INC.11/30/2005 
3376-835FLAVOXATE HYDROCHLORIDE TABLETS, 100 MG  HAMPTON LAINE, LLC11/30/2005