| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Wockhardt |
Toptramate, 25 mg, 50 mg, 100 mg and 200 mg tabs. |
90-353 |
9/1/2010 |
| Perrigo |
Imiquimod, 5% topical cream |
78-837 |
9/7/2010 |
| Watson |
Drospirenone/ethinyl estradiol, 3 mg/0.03 mg oral-28 tabs. |
90-081 |
9/7/2010 |
| Eroject |
Methylergonovine maleate, 0.2 mg/mL inj. |
40-889 |
9/13/2010 |
| Aurobindo |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg 80 mg and 100 mg caps. |
79-016 |
9/13/2010 |
| Sandoz |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-018 |
9/13/2010 |
| Dr. Reddy’s |
Mycophenolate mofetil, 500 mg tabs. |
90-464 |
9/13/2010 |
| Matrix |
Nifedipine, 30 mg, 60 mg and 90 mg extended-release tabs. |
90-602 |
9/13/2010 |
| Pharm Assoc |
Prednisolone sodium phosphate, 25 mg/5 mL oral suspension |
91-396 |
9/13/2010 |
| Watson |
Famciclovir, 125 mg, 250 mg and 500 mg tabs. |
78-278 |
9/14/2010 |
| Mikart |
Benzphetamine HCl, 25 mg and 50 mg tabs. |
90-473 |
9/15/2010 |
| Zydus |
Atomoxetine HCl, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-017 |
9/16/2010 |
| Actavis |
Fosinopril sodium/hydrochlorothiazide, 10 mg/12.5 mg and 20 mg/12.5 mg tabs. |
79-025 |
9/17/2010 |
| Boca |
Alprazolam, 0.25 mg, 0.5 mg, 1 mg and 2 mg tabs. |
90-248 |
9/17/2010 |
| Mylan |
Tacrolimus, 0.5 mg, 1 mg and 5 mg caps. |
90-596 |
9/17/2010 |
| Auribindo |
Ampicillin/sulbactam, EQ 10 gm base/vial; EQ 5 gm base/vial inj. |
90-339 |
9/20/2010 |
| Auribindo |
Ampicillin/sulbactam, EQ 1 gm base/vial; EQ 500 mg base/vial and EQ 2 gm base/vial/EQ 1 gm base/vial inj. |
90-340 |
9/20/2010 |
| Auribindo |
Ampicillin/sulbactam, EQ 1 gm base/vial; EQ 500 mg base/vial and EQ 2 gm base/vial/EQ 1 gm base/vial inj. |
90-349 |
9/20/2010 |
| Covenant |
Rifampin, 600 mg/vial inj. |
65-502 |
9/21/2010 |
| Luitpold |
Granisetron HCl, EQ 1 mg base/mL (EQ 1 mg base/mL) inj. |
91-274 |
9/22/2010 |
| Tentative Approvals |
| Hetero |
Lamivudine/nevirapine/stavudine, 150 mg/200 mg/30 mg tabs. |
200-244 |
9/10/2010 |
| Watson |
Norethindrone & ethinyl estradiol/ferrous fumarate, 0.4 mg & 0.035 mg/75 mg chewable tabs. |
78-892 |
9/13/2010 |
| Torrent |
Pantoprazole sodium, 20 mg and 40 mg delayed-release tabs. |
90-074 |
9/13/2010 |
| Torrent |
Duloxetine HCl, 20 mg, 30 mg and 60 mg delayed-release caps. |
90-774 |
9/14/2010 |
| Matrix |
Atazanavir sulfate, 150 mg caps. |
91-611 |
9/15/2010 |
| Zydus |
Duloxetine HCl, 20 mg, 30 mg and 60 mg delayed-release caps. |
90-728 |
9/16/2010 |
| Teva |
Donepezil HCl, 5 mg and 10 mg tabs. |
77-344 |
9/17/2010 |