|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
77-101 |
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, 0.15 MG/0.03 MG |
WATSON LABORATORIES, INC. |
5/8/2006 |
2 |
77-242 |
GABAPENTIN CAPSULES, 100 MG, 300 MG, AND 400 MG |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
5/12/2006 |
3 |
77-525 |
GABAPENTIN TABLETS, 600 MG AND 800 MG |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
5/12/2006 |
4 |
77-844 |
ABACAVIR SULFATE TABLETS, 300 MG (BASE) |
AUROBINDO PHARMA LIMITED |
5/17/2006 |
5 |
77-173 |
ONDANSETRON INJECTION USP (PRESERVATIVE-FREE), 2 MG/ML; 2 ML VIALS |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
5/19/2006 |
6 |
77-956 |
NEVIRAPINE TABLETS, 200 MG |
CIPLA LIMITED |
5/19/2006 |
7 |
77-172 |
ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
5/19/2006 |
8 |
76-780 |
ONDANSETRON INJECTION USP (PRESERVATIVE-FREE), 2 MG/ML; 2 ML VIALS |
HIKMA FARMACEUTICA (PORTUGAL), LDA |
5/22/2006 |
9 |
76-781 |
ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS |
HIKMA FARMACEUTICA (PORTUGAL), LDA |
5/22/2006 |
10 |
77-744 |
SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
MYLAN PHARMACEUTICALS, INC. |
5/23/2006 |
11 |
77-540 |
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG |
SYNTHON PHARMACEUTICALS, INC. |
5/24/2006 |
12 |
76-958 |
LOSARTAN POTASSIUM TABLETS, 25 MG, 50 MG, AND 100 MG |
TEVA PHARMACEUTICALS, USA |
5/24/2006 |
13 |
77-916 |
EFAVIRENZ TABLETS, 600 MG |
CIPLA LIMITED |
5/24/2006 |
14 |
77-459 |
LOSARTAN POTASSIUM TABLETS, 25 MG, 50 MG, AND 100 MG |
ROXANE LABORATORIES, INC. |
5/25/2006 |
15 |
76-052 |
SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG |
IVAX PHARMACEUTICALS, INC. |
5/25/2006 |
16 |
77-904 |
PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 40 MG, AND 80 MG |
WATSON LABORATORIES, INC. |
5/30/2006 |
17 |
76-981 |
ESCITALOPRAM OXALATE TABLETS, 5 MG, 10 MG, AND 20 MG |
ALPHAPHARM PTY. LTD. |
5/31/2006 |