|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
|
77-361 |
TRIMIPRAMINE MALEATE CAPSULES 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
AMIDE PHARMACEUTICAL, INC. |
8/2/2006 |
2 |
76-690 |
VENLAFAXINE HYDROCHLORIDE TABLETS 25 MG (BASE), 37.5 MG (BASE), 50 MG (BASE), 75 MG (BASE), AND 100 MG (BASE) |
TEVA PHARMACEUTICALS USA |
8/3/2006 |
3 |
77-704 |
FLUNISOLIDE NASAL SOLUTION USP, 0.025% (0.025 MG/SPRAY) METERED NASAL SPRAY |
Q-PHARMA LLC |
8/3/2006 |
4 |
77-051 |
FENTANYL TRANSDERMAL SYSTEM 25 MCG/HOUR, 50 MCG/HOUR, 75 MCG/HOUR, AND 100 MCG/HOUR |
LAVIPHARM LABORATORIES, INC. |
8/4/2006 |
5 |
40-615 |
TESTOSTERONE CYPIONATE INJECTION USP, 100 MG/ML AND 200 MG/ML |
SANDOZ CANADA, INC. |
8/10/2006 |
6 |
65-292 |
CEFOTAXIME FOP INJECTION USP, 10 G (BASE)/VIAL (PHARMACY BULK PACKAGE) |
ORCHID HEALTHCARE |
8/10/2006 |
7 |
65-293 |
CEFOTAXIME FOR INJECTION USP, 1 G(BASE)/VIAL AND 2 G(BASE)/VIAL PACKAGED IN INFUSION BOTTLES |
ORCHID HEALTHCARE |
8/10/2006 |
8 |
65-290 |
CEFOTAXIME FOR INJECTION USP, 500 MG (BASE)/VIAL, 1 G (BASE)/VIAL, AND 2 G (BASE)/VIAL |
ORCHID HEALTHCARE |
8/11/2006 |
9 |
76-465 |
SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
TEVA PHARMACEUTICALS USA |
8/11/2006 |
10 |
77-393 |
STERILE WATER FOR INJECTION USP, PACKAGED IN SINGLE-DOSE PLASTIC AMPULES |
TARO PHARMACEUTICALS IRELAND LTD. |
8/11/2006 |
11 |
77-407 |
SODIUM CHLORIDE INJECTION USP, 0.9% PACKAGED IN 5 ML & 10 ML SINGLE-DOSE PLASTIC AMPULES |
TARO PHARMACEUTICALS IRELAND LTD. |
8/11/2006 |
12 |
77-628 |
IBUPROFEN AND PSEUROEPHEDRINE HYDROCHLORIDE TABLETS USP, 200 MG/30 MG (OTC) |
DR. REDDY'S LABORATORIES LIMITED |
8/14/2006 |
13 |
77-705 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG |
GENPHARM INC. |
8/14/2006 |
14 |
77-862 |
BACLOFEN TABLETS USP, 20 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
8/14/2006 |
15 |
77-984 |
BACLOFEN TABLETS USP, 10 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
8/14/2006 |
16 |
77-813 |
ZONISAMIDE CAPSULES 25 MG, 50 MG, AND 100 MG |
BANNER PHARMACAPS, INC. |
8/16/2006 |
17 |
76-626 |
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.18 MG/0.035 MG, 0.215 MG/0.035 MG, AND 0.25 MG/0.035 MG, RESPECTIVELY; PACKAGED IN A 28-DAY CYCLE REGIMEN |
WATSON LABORATORIES, INC. |
8/17/2006 |
18 |
76-627 |
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.25 MG/0.035 MG, RESPECTIVELY; PACKAGED IN A 28-DAY CYCLE REGIMEN |
WATSON LABORATORIES, INC. |
8/17/2006 |
19 |
65-321 |
NYSTATIN TOPICAL POWDER USP, 100,000 UNITS/GRAM |
KV PHARMACEUTICAL COMPANY |
8/18/2006 |
20 |
77-662 |
GABAPENTIN TABLETS 600 MG AND 800 MG |
GLENMARK PHARMACEUTICALS LIMITED |
8/18/2006 |
21 |
77-787 |
METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG |
DR. REDDY'S LABORATORIES LTD. |
8/23/2006 |
22 |
77-242 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
8/24/2006 |
23 |
77-525 |
GABAPENTIN TABLETS 600 MG AND 800 MG |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
8/24/2006 |
24 |
40-729 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/500 MG |
INTERPHARM INC. |
8/25/2006 |
25 |
40-736 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/325 MG |
INTERPHARM INC. |
8/25/2006 |
26 |
40-746 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 10 MG/325 MG |
INTERPHARM INC. |
8/25/2006 |
27 |
40-748 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/500 MG |
INTERPHARM INC. |
8/25/2006 |
28 |
40-754 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/650 MG |
INTERPHARM INC. |
8/25/2006 |
29 |
40-757 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 10 MG/650 MG |
INTERPHARM INC. |
8/25/2006 |
30 |
40-769 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/750 MG |
INTERPHARM INC. |
8/28/2006 |
31 |
76-484 |
CIPROFLOXACIN INJECTION USP, 10 MG/ML, PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS |
ABRAXIS PHARMACEUTICAL PRODUCTS |
8/28/2006 |
32 |
76-992 |
CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
8/28/2006 |
33 |
76-993 |
CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 1200 MG/120 ML SINGLE-USE VIAL; PHARMACY BULK PACKAGE |
BEDFORD LABORATORIES |
8/28/2006 |
34 |
77-245 |
CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS |
HOSPIRA INC. |
8/28/2006 |
35 |
77-782 |
CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS |
SICOR PHARMACEUTICALS, INC. |
8/28/2006 |
36 |
77-812 |
CITALOPRAM HYDROBROMIDE ORAL SOLUTION 10 MG (BASE)/5 ML |
AUROBINDO PHARMA LIMITED |
8/28/2006 |
37 |
77-878 |
METOCLOPRAMIDE TABLETS USP, 5 MG AND 10 MG |
VINTAGE PHARMACEUTICALS, LLC |
8/28/2006 |
38 |
40-750 |
SPIRONOLACTONE TABLETS USP, 25 MG, 50 MG, AND 100 MG |
VINTAGE PHARMACEUTICALS, LLC |
8/29/2006 |
39 |
65-197 |
CEFOTAXIME FOR INJECTION USP, 1 GRAM/VIAL |
WOCKHARDT LIMITED |
8/29/2006 |
40 |
76-388 |
LAMOTRIGINE TABLETS 25 MG, 100 MG, 150 MG, AND 200 MG |
TEVA PHARMACEUTICALS USA |
8/30/2006 |
41 |
40-653 |
GLYCOPYRROLATE TABLETS 1 MG AND 2 MG |
KALI LABORATORIES, INC. |
8/31/2006 |
42 |
77-531 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG |
COBALT PHARMACEUTICALS, INC. |
8/31/2006 |