|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
76-422 |
CICLOPIROX TOPICAL SUSPENSION USP, 0.77% (LOTION)
0.77% |
ALTANA, INC. |
8/6/2004 |
2 |
75-115 |
NITROGLYCERIN TRANSDERMAL SYSTEM 0.2 MG/HOUR AND
0.4 MG/HOUR |
SCHWARZ PHARMA, INC. |
8/10/2004 |
3 |
76-323 |
ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML;
PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
8/10/2004 |
4 |
76-851 |
LEVOCARNITINE ORAL SOLUTION, USP 1 G/10 ML |
LYNE LABORATORIES, INC. |
8/10/2004 |
5 |
40-612 |
METHYLPREDNISOLONE SODIUM SUCCINATE FOR
INJECTION, USP 1 GRAM (BASE)/VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
8/12/2004 |
6 |
76-368 |
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
20 mEq |
EURAND INC. |
8/18/2004 |
7 |
76-414 |
MILRINONE LACTATE IN 5% DEXTROSE INJECTION 20 MG
(BASE)/100 ML SINGLE-DOSE PLASTIC CONTAINER |
B. BRAUN MEDICAL, INC. |
8/18/2004 |
8 |
77-025 |
NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS) 100
MG |
MYLAN PHARMACEUTICALS, INC. |
8/18/2004 |
9 |
75-728 |
LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML |
L. PERRIGO COMPANY |
8/20/2004 |
10 |
75-815 |
LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML |
MORTON GROVE PHARMACEUTICALS, INC. |
8/20/2004 |
11 |
76-529 |
LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML |
RANBAXY LABORATORIES LIMITED |
8/20/2004 |
12 |
76-792 |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
TABLETS, USP 50 MG/25 MG, 100 MG/25 MG, AND 100 MG/50 MG |
MYLAN PHARMACEUTICALS, INC. |
8/20/2004 |
13 |
76-805 |
LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
8/20/2004 |
14 |
76-239 |
MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) (OTC)
5% |
HARMONY LABS, INC. |
8/24/2004 |
15 |
76-774 |
HALOPERIDOL INJECTION, USP (PRESERVATIVE-FREE) 5
MG (BASE)/ML; PACKAGED IN 5 MG (BASE)/1 ML SYRINGES |
APOTEX CORP. |
8/25/2004 |
16 |
76-791 |
HALOPERIDOL INJECTION, USP (PRESERVATIVE-FREE) 5
MG (BASE)/ML; PACKAGED IN 5 MG (BASE)/1 ML SINGLE-USE VIALS |
APOTEX CORP. |
8/25/2004 |
17 |
76-814 |
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES 5 MG, 10 MG, AND 15 MG |
ABLE LABORATORIES, INC. |
8/25/2004 |
18 |
76-828 |
HALOPERIDOL INJECTION, USP 5 MG (BASE)/ML;
PACKAGED IN 50 MG (BASE)/10 ML MULTIPLE-DOSE VIALS |
APOTEX CORP. |
8/25/2004 |
19 |
76-870 |
ALLOPURINOL SODIUM FOR INJECTION 500 MG
(BASE)/VIAL |
BEDFORD LABORATORIES |
8/26/2004 |
20 |
40-564 |
DOXYLAMINE SUCCINATE TABLETS, USP (OTC) 25 MG |
LNK INTERNATIONAL, INC. |
8/27/2004 |
21 |
76-699 |
CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING
TABLETS 10 MG/100 MG, 25 MG/100 MG, AND 25 MG/250 MG |
SCHWARZ PHARMA, INC. |
8/27/2004 |
22 |
76-830 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
PHARMAFORCE, INC. |
8/31/2004 |