FDA’s ANDA Approvals
Executive Summary
Generic drug approvals for late August.
Applicant |
Active Ingredients |
Number |
Date Approved |
Watson |
Lidocaine, 5% topical patch |
200-675 |
8/23/2012 |
Astral |
Nafcillin sodium, EQ 10 gm base/vial, inj. |
90-580 |
8/24/2012 |
Astral |
Nafcillin sodium, EQ 1 gm base/vial and EQ 2 gm base/vial, inj. |
90-582 |
8/24/2012 |
Tamarang |
Rocuronium bromide, 50 mg/5 mL (10 mg/ mL) and 100 mg/10 mL (10 mg/ mL), inj. |
91-115 |
8/27/2012 |
Rouses Point |
Levetiracetam, 500 mg and 750 mg, extended-release tabs. |
202-524 |
8/27/2012 |
Sagent |
Flumazenil, 0.5 mg/mL (0.1 mg/mL) and 1 mg/ 10 mL (0.1 mg/mL), inj. |
90-584 |
8/28/2012 |
Onco Therapies |
Topotecan HCl, EQ 4 mg base/vial, inj. |
91-542 |
8/28/2012 |
Lyne |
Clindamycin palmitate HCl, EQ 75 mg base/5 mL oral solution, |
201-821 |
8/28/2012 |
Sagent |
Caffeine citrate, EQ 30 mg base/3 mL (EQ 10 mg base/mL), intravenous solution |
90-827 |
8/29/2012 |
Sagent |
Caffeine citrate, EQ 30 mg base/3 mL (EQ 10 mg base/mL), oral solution |
91-102 |
8/29/2012 |
Watson |
Armodafinil, 50 mg, 100 mg, 150 mg, 200 mg and 2500 mg, tabs. |
200-156 |
8/29/2012 |