• 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 2001

 ANDA NumberDrug NameApplicantApproval Date
175-916RIMANTADINE HYDROCHLORIDE TABLETS 100 MGCOREPHARMA LLC11/2/01
275-682IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MGBASF CORPORATION11/14/01
375-347OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, 20 MG, AND 40 MGANDRX PHARMACEUTICALS, INC.11/16/01
465-034DAUNORUBICIN HYDROCHLORIDE INJECTION 5 MG (BASE)/ML; 4 ML SINGLE-DOSE VIALSSUPERGEN, INC.11/20/01
576-117IBUPROFEN TABLETS, USP (OTC) 200 MGDR. REDDY'S LABORATORIES LIMITED11/20/01
675-569THALLOUS CHLORIDE TL-201 INJECTION, USP 1 mCi/MLMOUNT SINAI MEDICAL CENTER11/21/01
775-749DILTIAZEM HYDROCHLORIDE INJECTION 5 MG/ML, PACKAGED IN 25 MG/5 ML SYRINGE AND 50 MG/10 ML DILUTE-A-JET SYRINGEINTERNATIONAL MEDICATION SYSTEMS LIMITED11/21/01
875-915TIOCONAZOLE VAGINAL OINTMENT 6.5% (OTC)L. PERRIGO COMPANY11/21/01
940-434OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG, AND 10 MG/325 MGENDO PHARMACEUTICALS, INC.11/23/01
1075-870FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML SINGLE-DOSE VIAL)ABBOTT LABORATORIES11/23/01
1175-905FAMOTIDINE INJECTION 10 MG/ML; PACKAGED IN 4 ML & 20 ML MULTIPLE-DOSE VIALSABBOTT LABORATORIES11/23/01
1275-794ACETAMINOPHEN, ASPIRIN, AND CAFFEINE TABLETS, USP 250 MG/250 MG/65 MG, RESPECTIVELY (OTC)L. PERRIGO COMPANY11/26/01
1376-057ETHAMBUTOL HYDROCHLORIDE TABLETS, USP 400 MGBARR LABORATORIES, INC.11/26/01
1475-404FAMOTIDINE TABLETS, USP (OTC) 10 MGDANBURY PHARMACAL, INC.11/28/01
1575-721LEUPROLIDE ACETATE INJECTION 1 MG/0.2 ML (2.8 ML MULTIPLE-DOSE VIALS)GENZYME CORPORATION11/29/01
1675-998PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MGMUTUAL PHARMACEUTICAL COMPANY11/29/01
1775-231BUTALBITAL, ASPIRIN, CAFFEINE, & CODEINE PHOSPHATE CAPS, USP 50 MG/325 MG/40 MG/30 MGANABOLIC, INC.11/30/01
1875-829ETODOLAC EXTENDED-RELEASE TABLETS 400 MG 500 MGANDRX PHARMACEUTICALS, L.L.C.11/30/01
1975-840NORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 21-DAY & 28-DAY REGIMENS; 0.3 MG/0.03 MG NOTE:28-DAY REGIMEN ALSO CONTAINS 7 INERT TABLETS.DURAMED PHARMACEUTICALS, INC.11/30/01