| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| ACS Dobfar |
Cefoxitin sodium, EQ 1 gm base/vial and EQ 2 gm base/vial inj. |
65-414 |
6/12/2009 |
| Actavis Totowa |
Risperidone, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tabs. |
78-071 |
6/17/2009 |
| Lupin |
Ethambutol HCl, 100 mg and 400 mg tabs. |
78-939 |
6/17/2009 |
| Sun |
Vecuronium bromide, 10 mg/vial and 20 mg/vial inj. |
79-001 |
6/17/2009 |
| Xttrium |
Chlorthexidine gluconate, 0.12% dental solution |
77-789 |
6/18/2009 |
| Sun |
Quinapril HCl, EQ 5 mg base, EQ 10 mg base, EQ 20 mg base and EQ 40 mg base tabs. |
90-800 |
6/18/2009 |
| Sandoz |
Galantamine hydrobromide, EQ 4 mg base, EQ 8 mg base and EQ 12 mg base tabs. |
77-589 |
6/22/2009 |
| Natco |
Granisetron HCl, EQ 1 mg base tabs. |
78-969 |
6/22/2009 |
| Pharmaforce |
Progesterone, 50 mg/mL inj. |
90-845 |
6/22/2009 |
| Glenmark |
Alclometasone dipropionate, 0.05% topical cream |
79-061 |
6/23/2009 |
| Alembic |
Metronidazole, 375 mg caps. |
79-065 |
6/23/2009 |
| Mikart |
Meperidine HCl, 50 mg, 75 mg, 100 mg and 150 mg tabs. |
40-893 |
6/24/2009 |
| Watson |
Levonorgestrel, 0.75 mg tabs. |
78-666 |
6/24/2009 |
| Akorn |
Epirubicin HCl, 2 mg/mL inj. |
90-163 |
6/24/2009 |
| Bausch & Lomb |
Dorzolamide HCl, EQ 2% base ophthalmic solution/drops |
090-143 |
6/25/2009 |
| Hospira |
Azithromycin, EQ 500 mg base/vial inj. |
065-500 |
6/26/2009 |
| Hospira |
Azithromycin, EQ 500 mg base/vial inj. |
065-511 |
6/26/2009 |
| Ranbaxy |
Oxcarbazepine, 300 mg/5 mL suspension |
078-734 |
6/26/2009 |
| Barr |
Norgestimate/ethinyl estradiol, 0.18 mg/0.025 mg tabs. |
076-784 |
6/29/2009 |
| Tentative Approvals |
| Apotex |
Gatifloxacin, 0.3% ophthalmic solution |
79-084 |
6/12/2009 |
| Roxane |
Montelukast sodium, 10 mg tabs. |
90-655 |
6/16/2009 |
| Dr. Reddy's |
Quetiapine fumarate, 25 mg tabs. |
77-380 |
6/17/2009 |
| Hospira |
Oxaliplatin, 5 mg/mL inj. |
78-813 |
6/18/2009 |
| West Ward |
Granisetron HCl, 1 mg/mL inj. |
78-629 |
6/19/2009 |
| Matrix |
Lamivudine, 150 mg tabs. |
78-545 |
6/22/2009 |
| Lupin |
Levofloxacin, 250 mg, 500 mg and 750 mg tabs. |
78-424 |
6/25/2009 |
| Teva |
Montelukast sodium, 4 mg and 5 mg tabs. |
78-723 |
6/25/2009 |
| Mylan |
Montelukast sodium, 4 mg and 5 mg chewable tabs. |
79-142 |
6/25/2009 |
| Dr. Reddy's |
Olanzapine, 2.5 mg, 5 mg, 7.5 mg and 10 mg tabs. |
76-255 |
6/26/2009 |
| Dr. Reddy's |
Valacyclovir HCl, 500 mg and 1,000 mg tabs. |
79-012 |
6/26/2009 |
| Dr. Reddy's |
Olanzapine, 15 mg and 20 mg tabs. |
76-133 |
6/30/2009 |
| Sun |
Azelastine HCl, 0.05% ophthalmic solution |
78-738 |
6/30/2009 |