| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
40-455 |
NOREPINEPHRINE BITARTRATE INJECTION,
USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS |
GENSIA SICOR PHARMACEUTICALS, INC. |
3/3/2003 |
| 2 |
40-463 |
ORPHENADRINE CITRATE INJECTION, USP 30MG/ML, PACKAGED IN 60 MG/2 ML VIALS |
BEDFORD LABORATORIES |
3/4/2003 |
| 3 |
40-399 |
PREDNISOLONE SYRUP, USP 15 MG/5 ML |
PHARMACEUTICAL ASSOCIATES, INC. |
3/5/2003 |
| 4 |
40-497 |
PHENTERMINE HYDROCHLORIDE CAPSULES, USP 15 MG |
ABLE LABORATORIES, INC. |
3/13/2003 |
| 5 |
76-174 |
ETODOLAC EXTENDED-RELEASE TABLETS 400 MG, 500 MG, AND 600 MG |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
3/13/2003 |
| 6 |
40-413 |
METHOCARBAMOL TABLETS, USP 500 MG AND 750 MG |
ABLE LABORATORIES, INC. |
3/17/2003 |
| 7 |
40-442 |
CARBINOXAMINE MALEATE TABLETS, USP 4 MG |
MIKART, INC. |
3/19/2003 |
| 8 |
65-132 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG
(BASE)/5 ML |
RANBAXY LABORATORIES, LTD. |
3/19/2003 |
| 9 |
76-367 |
AMCINONIDE OINTMENT, USP 0.1% |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
3/19/2003 |
| 10 |
40-515 |
PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML; (1 ML AMPULES) |
PHARMAFORCE, INC. |
3/19/2003 |
| 11 |
75-736 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG AND 10 MG/25 MG |
IVAX PHARMACEUTICALS, INC. |
3/25/2003 |
| 12 |
75-183 |
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML |
HI-TECH PHARMACAL CO., INC. |
3/26/2003 |
| 13 |
65-115 |
CEFADROXIL FOR ORAL SUSPENSION, USP 125 MG/5 ML, 250 MG/5 ML, AND 500 MG/5 ML |
RANBAXY LABORATORIES LIMITED |
3/26/2003 |
| 14 |
40-441 |
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 500 MG/30 MG |
ANDRX PHARMACEUTICALS, L.L.C. |
3/27/2003 |
| 15 |
76-421 |
FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG |
RANBAXY LABORATORIES LIMITED |
3/28/2003 |
| 16 |
40-488 |
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 500 MG/60 MG |
ANDRX PHARMACEUTICALS L.LC. |
3/28/2003 |
| 17 |
76-354 |
TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE) |
MYLAN PHARMACEUTICALS, INC. |
3/28/2003 |
| 18 |
75-823 |
CALCITRIOL INJECTION 0.001MG/ML AND 0.002 MG/ML PACKAGED IN 1 ML FILL IN 2ML SINGLE-DOSE VIALS |
GENSIA SICOR PHARMACEUTICALS, INC. |
3/31/2003 |
| 19 |
76-398 |
TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE) |
EGIS PHARMACEUTICALS, LTD. |
3/31/2003 |
| 20 |
75-553 |
IPRATROPIUM BROMIDE NASAL SOLUTION,
(NASAL SPRAY) 0.06% (0.042 MG/SPRAY) |
DEY, L.P. |
3/31/2003 |
| 21 |
75-552 |
IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY) |
DEY, L.P. |
3/31/2003 |
| 22 |
76-025 |
IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY) |
BAUSCH & LOMB PHARMACEUTICALS,
INC. |
3/31/2003 |
| 23 |
76-103 |
IPRATROPIUM BROMIDE NASAL SOLUTION 0.06% (NASAL SPRAY) |
BAUSCH & LOMB PHARMACEUTICALS,
INC. |
3/31/2003 |
| 24 |
74-539 |
TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) |
PHARMACHEMIE B.V. |
3/31/2003 |
