|
ANDA Number |
Drug Name |
Applicant |
Approval Date |
1 |
75-702 |
CROMOLYN SODIUM NASAL SOLUTION, USP 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 26 ML BOTTLE. |
BAUSCH & LOMB PHARMACEUTICALS, INC. |
7/3/01 |
2 |
75-712 |
CARBAMAZEPINE TABLETS, USP (CHEWABLE) 100 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
7/5/01 |
3 |
40-407 |
PROCHLORPERAZINE SUPPOSITORIES, USP 2.5 MG, 5 MG, AND 25 MG |
ABLE LABORATORIES, INC. |
7/11/01 |
4 |
75-735 |
PENTAZOCINE AND NALOXONE HCL TABLETS, USP 50 MG (BASE)/0.5 MG (BASE) |
AMIDE PHARMACEUTICAL, INC. |
7/11/01 |
5 |
75-838 |
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG (WHITE TABLETS AND PINK TABLETS) |
ABLE LABORATORIES, INC. |
7/11/01 |
6 |
75-809 |
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP TRIPHASIC REGIMEN 0.05 MG/0.03 MG, 0.075 MG/0.04 MG,
AND 0.125 MG/0.03 MG; 21-DAY AND 28-DAY CYCLES. |
DURAMED PHARMACEUTICALS, INC. |
7/16/01 |
7 |
40-390 |
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/325 MG/40 MG |
ABLE LABORATORIES, INC. |
7/23/01 |
8 |
40-394 |
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/500 MG/40 MG |
ABLE LABORATORIES, INC. |
7/23/01 |
9 |
75-278 |
PACLITAXEL INJECTION 6 MG/ML; PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML AND 300 MG/50 ML MULTIPLE-DOSE
VIALS. |
MYLAN PHARMACEUTICALS, INC. |
7/23/01 |
10 |
75-611 |
FAMOTIDINE TABLETS, USP 20 MG AND 40 MG |
TORPHARM |
7/23/01 |
11 |
75-626 |
KETOROLAC TROMETHAMINE INJECTION, USP 30 MG/ML (MULTIPLE-DOSE VIALS) |
APOTEX CORP. |
7/24/01 |
12 |
75-671 |
MEGESTROL ACETATE ORAL SUSPENSION 40 MG/ML |
PAR PHARMACEUTICAL, INC. |
7/25/01 |
13 |
74-800 |
CROMOLYN SODIUM NASAL SOLUTION, USP 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 13 ML & 26 ML BOTTLES |
ALPHARMA, U.S. PHARMACEUTICALS DIVISION |
7/26/01 |
14 |
75-512 |
FAMOTIDINE TABLETS, USP (OTC) 10 MG |
IVAX PHARMACEUTICALS, INC. |
7/26/01 |
15 |
75-993 |
LACTULOSE SOLUTION, USP 10 G/15 ML |
VINTAGE PHARMACEUTICALS, INC. |
7/26/01 |
16 |
65-081 |
CEPHALEXIN FOR ORAL SUSPENSION, USP 125 MG/5 ML AND 250 MG/5 ML |
RANBAXY LABORATORIES LIMITED |
7/27/01 |
17 |
75-190 |
PACLITAXEL INJECTION 6 MG/ML; PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML, AND 300 MG/50 ML MULTIPLE-DOSE VIALS. |
BEDFORD LABORATORIES |
7/27/01 |
18 |
75-085 |
HYDROCORTISONE VALERATE OINTMENT, USP 0.2% |
ALTANA INC. |
7/31/01 |
19 |
75-442 |
FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG |
ALPHAPHARM PTY. LTD. |
7/31/01 |