DA's ANDA Approvals（10月2日）
公開日時 2011/10/05 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sun Pharma |
Ranitidine HCl EQ 15 mg base/ml syrup oral |
91-091 |
9/20/2011 |
| Hikma |
Glycopyrrolate 0.2mg/ml inj. |
90-963 |
9/21/2011 |
| Zenotech |
Ondansetron 2 mg/ml inj. |
90-224 |
9/23/2011 |
| Zenotech |
Ondansetron 2mg/ml inj |
90-225 |
9/23/2011 |
| Apotex |
Tamoxifen citrate EQ 10 mg base, EQ 20mg base tabs. |
90-878 |
9/23/2011 |
| Roxane |
Doxercalciferol .5mcg, 1mcg, 2.5mcg caps. |
91-433 |
N/A |
| Watson |
Ethinyl estradiol / norethindrone 0.035 mg /0.4 mg chewable tabs. |
78-892 |
9/26/2011 |
| Lannett Holdings |
Loxapine succinate EQ 5 mg base, EQ 10 mg base, EQ 25 mg base, EQ50 mg base caps. |
90-695 |
9/26/2011 |
| Apotex |
Galantamine hydrobromide EQ 4 mg base, EQ 8 mg base, EQ 12 mg base tabs. |
77-781 |
9/27/2011 |
| Tentative Approvals |
|
|
|
| Mylan |
Doxercalciferol 2 mcg/ml inj. |
91-101 |
9/20/2011 |
| Glenmark Generics |
Zolmitriptan 2.5 mg, 5 mg tabs. |
201-779 |
9/21/2011 |
| Cipla |
Lamivudine/zidovudine 30 mg/60 mg tabs. |
201-151 |
9/22/2011 |
| Roxan |
Doxercalciferol 0.5 mcg, 1 mcg, 2.5 mcg caps. |
91-433 |
9/23/2011 |
| Dr. Reddys |
Zoledronic acid 4 mg inj. |
91-186 |
9/27/2011 |
| Dr. Reddys |
Zoledronic acid 4 mmg inj. |
91-187 |
9/27/2011 |
| Torrent |
Memantine HCl 5 mg, 10 mg tabs. |
200/155 |
9/27/2011 |
| Perrigo Israel |
Clobetasol propionate 0.05% topical foam |
201-402 |
9/27/2011 |
| Onco Therapies |
Oxaliplatin 5 mg/ ml inj. |
91-358 |
9/28/2011 |
（The Pink Sheet 10月2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