FDA’s ANDA Approvals
Executive Summary
Generic drug approvals and tentative approvals for late July.
|
Applicant |
Active Ingredients |
Number |
Date Approved |
|
Teva |
Ramelteon, 8 mg tabs. |
91-693 |
7/26/2013 |
|
Actavis |
Doxepin HCl., EQ 3 mg base and EQ 6 mg base tabs. |
201-951 |
7/26/2013 |
|
Apotex |
Fenofibrate, 43 mg and 130 mg, caps. |
202-252 |
7/26/2013 |
|
Taro |
Levocetirizine dihydrochloride, 2.5 mg/5 mL oral solution |
202-673 |
7/26/2013 |
|
Perrigo Israel |
Fluticasone propionate, 0.05% topical lotion |
91-553 |
7/30/2013 |
|
Accord Hlthcare |
Lisinopril, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tabs. |
202-554 |
7/30/2013 |
|
Aurolife |
Dextroamphetamine sulfate, 5 mg and 10 mg tabs. |
202-893 |
7/31/2013 |
|
Tentative Approvals |
|||
|
Par |
Cyclobenzaprine HCl., 15 mg and 30 mg extended-release caps. |
90-864 |
7/26/2013 |
|
Lupin |
Armodafinil, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg tabs. |
200-751 |
7/26/2013 |
|
Lupin |
Doxycycline, 40 mg caps. |
91-277 |
7/29/2013 |
|
Apotex |
Eletriptan hydrobromide, 20 mg and 40 mg tabs. |
201-536 |
7/29/2013 |
|
Sandoz |
Sitagliptin; metformin HCl., 50 mg/500 mg and 50 mg/1000 mg tabs. |
202-388 |
7/30/2013 |
|
Strides Arcolab |
Emtricitabine/tenofovir disoproxil fumarate, 200 mg/300 mg tabs. |
91-055 |
7/31/2013 |