FDA's ANDA Approvals（6月14日）
公開日時 2010/06/15 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Wockhardt |
Valacyclovir HCl, EQ 500 mg base and EQ 1 gm base tabs. |
90-216 |
5/24/2010 |
| Mikart |
Chlorzoxazone, 375 mg and 750 mg tabs. |
40-861 |
6/1/2010 |
| Lupin |
Lamotrigine, 25 mg, 100 mg, 150 mg and 200 mg tabs. |
78-691 |
6/1/2010 |
| Matrix |
Gabapentin, 600 mg and 800 mg tabs. |
90-335 |
6/1/2010 |
| APP |
Oxaliplatin, 50 mg/vial and 100 mg/vial IV infusion inj. |
78-819 |
6/2/2010 |
| Pliva |
Adapalene, 0.1% topical gel |
90-962 |
6/2/2010 |
| Cadista |
Meclizine HCl, 12.5 mg and 25 mg tabs. |
40-659 |
6/4/2010 |
| Vintage |
Folic acid, 1 mg tabs. |
40-756 |
6/4/2010 |
| Breckenridge |
Terbinafine HCl, EQ 250 mg base tabs. |
77-714 |
6/4/2010 |
| Alkem |
Cefuroxime axetil, EQ 250 mg base and EQ 500 mg base tabs. |
65-496 |
6/7/2010 |
| Hetero |
Finasteride, 5 mg tabs. |
90-061 |
6/7/2010 |
| Paddock |
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate, 236 gm/bot; 2.97 gm/bot; 6.74 gm/bot; 5.86 gm/bot; 22.74 gm/bot oral solution |
90-769 |
6/7/2010 |
| Mylan |
Hydroxyzine HCl, 10 mg, 25 mg and 50 mg tabs. |
91-176 |
6/7/2010 |
| Ratiopharm |
Risperidone, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg orally disintegrating tabs. |
77-784 |
6/8/2010 |
| Strides Arcolab |
Fosphenytoin sodium, EQ 50 mg phenytoin na/mL inj. |
78-736 |
6/8/2010 |
| Impax |
Carbidopa; levodopa, 10 mg, 100 mg; 25 mg, 100 mg and 25 mg, 250 mg orally disintegrating tabs. |
90-631 |
6/8/2010 |
| Matrix |
Simvastatin, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tabs. |
90-868 |
6/8/2010 |
| Aurobindo |
Sulfamethoxazole; trimethoprim, 200 mg/5 mL; |
91-348 |
6/8/2010 |
| 40 mg/5 mL oral suspension |
| Mikart |
Acetaminophen; hydrocodone bitartrate, 325 mg; 2.5 mg tabs. |
40-846 |
6/9/2010 |
| Mikart |
Acetaminophen; hydrocodone bitartrate, 650 mg; 5 mg tabs. |
40-849 |
6/9/2010 |
| Fresenius Kabi |
Oxaliplatin, 5 mg/mL inj. |
78-811 |
6/10/2010 |
| Tentative Approvals |
| Dr. Reddy's |
Zafirlukast, 10 mg and 20 mg tabs. |
90-372 |
6/1/2010 |
| Hetero |
Finasteride, 1 mg tabs. |
90-060 |
6/7/2010 |
| Zydus |
Donepezil HCl, 5 mg and 10 mg orally disintegrating tabs. |
90-175 |
6/7/2010 |
| Hikma |
Donepezil HCl, 5 mg and 10 mg tabs. |
90-247 |
6/7/2010 |
| Zydus |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
78-920 |
6/10/2010 |
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