 |
Approvals -
February 2004
| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
76-491 |
POLYETHYLENE GLYCOL 3350, KCL, NaHCO3 & NACL
FOR ORAL SOLUT 420 G, 1.48 G, 5.72 G, AND 11.2 G, RESPECTIVELY
PER BOTTLE |
SCHWARZ PHARMA, INC. |
2/5/2004 |
| 2 |
65-088 |
NEOMYCIN & POLYMYXIN B SULFATES, & BACITRACIN
ZN OPHTHAL OIN 3.5 MG (BASE), 10,000 UNITS, AND 400 UNITS,
RESPECTIVELY, PER GRAM |
AKORN, INC. |
2/6/2004 |
| 3 |
76-636 |
OXYCODONE HYDROCHLORIDE TABLETS, USP 15 MG,
AND 30 MG |
AMIDE PHARMACEUTICAL, INC. |
2/6/2004 |
| 4 |
76-118 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG,
20 MG, AND 40 MG |
KV PHARMACEUTICAL COMPANY |
2/11/2004 |
| 5 |
76-402 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG,
20 MG, AND 40 MG |
EON LABS, INC. |
2/11/2004 |
| 6 |
76-267 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG,
20 MG, AND 40 MG |
ANDRX PHARMACEUTICALS, LLC |
2/11/2004 |
| 7 |
76-333 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG,
20 MG, AND 40 MG |
IVAX PHARMACEUTICALS, INC. |
2/11/2004 |
| 8 |
76-430 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG,
20 MG, AND 40 MG |
MYLAN PHARMACEUTICALS, INC. |
2/11/2004 |
| 9 |
76-211 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG,
20 MG, AND 40 MG |
TEVA PHARMACEUTICALS USA |
2/11/2004 |
| 10 |
40-461 |
MERCAPTOPURINE TABLETS, USP 50 MG |
PROMETHEUS LABORATORIES, INC. |
2/11/2004 |
| 11 |
76-476 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG,
20 MG, AND 40 MG |
GENPHARM, INC. |
2/11/2004 |
| 12 |
76-348 |
BENAZEPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20
MG/12.5 MG, AND 20 MG/25 MG |
IVAX PHARMACEUTICALS, INC. |
2/11/2004 |
| 13 |
76-612 |
BENAZEPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20
MG/12.5 MG, AND 20 MG/25 MG |
GENPHARM, INC. |
2/11/2004 |
| 14 |
65-130 |
CEFIXIME TABLETS, USP 400 MG |
LUPIN LIMITED |
2/12/2004 |
| 15 |
40-528 |
MERCAPTOPURINE TABLETS, USP 50 MG |
ROXANE LABORATORIES |
2/13/2004 |
| 16 |
76-345 |
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS
1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG |
IVAX PHARMACEUTICALS, INC. |
2/18/2004 |
| 17 |
65-129 |
CEFIXIME FOR ORAL SUSPENSION, USP 100 MG/5 ML
|
LUPIN LIMITED |
2/23/2004 |
| 18 |
76-455 |
DESOGESTREL AND ETHINYL ESTRADIOL TABLETS
0.10 MG/0.025 MG, 0.125 MG/0.025 MG, 0.15 MG/0.025 MG; 28-DAY
TRIPHASIC REGIMEN |
BARR LABORATORIES, INC. |
2/24/2004 |
| 19 |
40-529 |
METHAMPHETAMINE HYDROCHLORIDE TABLETS, USP 5
MG |
ABLE LABORATORIES |
2/25/2004 |
| 20 |
76-342 |
BENAZEPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20
MG/12.5 MG, AND 20 MG/25 MG |
ANDRX PHARMACEUTICALS, LLC |
2/11/2004 |
| 21 |
76-344 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG,
20 MG, AND 40 MG |
RANBAXY LABORATORIES LIMITED |
2/11/2004 |
| 22 |
76-631 |
BENAZEPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20
MG/12.5 MG, AND 20 MG/25 MG |
EON LABS, INC. |
2/11/2004 |
| 23 |
76-688 |
BENAZEPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20
MG/12.5 MG, AND 20 MG/25 MG |
MYLAN PHARMACEUTICALS, INC. |
2/11/2004 |
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Date created: 3/4/2004 |
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