FDA's ANDA Approvals（10月11日）
公開日時 2010/10/13 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Ethypharm |
Buprenorphine HCl, EQ 2 mg base and EQ 8 mg base sublingual tabs. |
90-622 |
9/24/2010 |
| Sandoz |
Ethinyl estradiol/levonorgestrel, 0.03 mg/0.15 mg tabs. |
79-064 |
9/27/2010 |
| Strides |
Lidocaine HCl, 2% inj. |
90-665 |
9/27/2010 |
| Bioniche |
Fludarabine phosphate, 50 mg/2 mL (25 mg/mL) inj. |
90-724 |
9/27/2010 |
| Roxane |
Oxymorphone HCl, 5 mg and 10 mg tabs. |
90-964 |
9/27/2010 |
| Septodont |
Prilocaine HCl, 4% inj. |
79-235 |
9/29/2010 |
| Tris |
Levetiracetam, 100 mg/mL solution |
90-461 |
9/30/2010 |
| Strides |
Lidocaine HCl, 0.5% and 1% inj. |
91-058 |
9/30/2010 |
| Teva |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-022 |
10/1/2010 |
| Lek |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
77-424 |
10/6/2010 |
| Roxane |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
77-459 |
10/6/2010 |
| Aurobindo |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-083 |
10/6/2010 |
| Apotex |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-790 |
10/6/2010 |
| Watson |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
91-129 |
10/6/2010 |
| Mylan |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
91-590 |
10/6/2010 |
| Tentative Approvals |
| Torrent |
Clopidogrel, 75 mg tabs. |
90-844 |
9/22/2010 |
| Watson |
Famciclovir, 125 mg, 250 mg and 500 mg tabs. |
78-278 |
9/24/2010 |
| Sun |
Riluzole, 50 mg tabs. |
91-417 |
9/27/2010 |
| Sun |
Rosuvastatin calcium, 5 mg, 10 mg, 20 mg and 40 mg tabs. |
79-169 |
9/28/2010 |
| Invagen |
Abacavir sulfate, 300 mg tabs. |
91-560 |
9/29/2010 |
| Sun |
Carbidopa/levodopa/entacapone, 25 mg/100 mg/200 mg and 37.5 mg/150 mg/200 mg tabs. |
79-085 |
9/30/2010 |
| Bedford |
Mycophenolate mofetil HCl, 500 mg inj. |
90-311 |
9/30/2010 |
| Mylan |
Clopidogrel bisulfate, 75 mg tabs. |
77-665 |
10/4/2010 |
（The Pink Sheet 10月11日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから