FDA's ANDA Approvals（12月19日）
公開日時 2011/12/20 04:00
Generic drug approvals and tentative approvals for mid-December.
|
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Lannett Holdings |
Hydrochlorothiazide; Triamterene 25 mg and 37.5 mg, caps. |
201-407 |
12/9/2011 |
| Onco Therapies |
Cytarabine 20 mg/ml, inj. |
200-914 |
12/13/2011 |
| Onco Therapies |
Cytarabine 20 mg/ml, inj. |
200-915 |
12/13/2011 |
| Onco Therapies |
Cytarabine 20 mg/ml, inj. |
200-916 |
12/13/2011 |
| Ranbaxy |
Acetaminophen 650 mg, extended-release tabs. |
78-569 |
12/14/2011 |
| Actavis Elizabeth |
Doxycycline Hyclate 75 mg and 100 mg, delayed release tabs. |
90-134 |
12/14/2011 |
| Tentative Approvals |
|
|
|
| Lupin |
Duloxetine HCl 20 mg, 30 mg and 60 mg, delayed release caps. |
90-694 |
12/8/2011 |
| Teva |
Atazanavir Sulfate 100 mg, 150 mg, 200 mg and 300 mg, caps. |
91-673 |
12/8/2011 |
| Akorn |
Dexmedetomidine HCl 100 mcg (base) /mL, inj. |
202-585 |
12/12/2011 |
| Mutual |
Ibandronate Sodium 150 mg |
78-996 |
12/13/2011 |
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