FDA's ANDA Approvals
Executive Summary
US Generic drug approvals and tentative approvals for mid- and late January.
|
Sponsor |
Active Ingredient |
Dosage; Formulation |
Approval Date |
|
Sandoz |
Aspirin/dipyridamole |
25 mg/200 mg; extended-release capsule |
1/18/2017 |
|
Renaissance |
Methocarbamol |
1 gm/10 mL (100 mg/mL); IM-IV solution |
1/19/2017 |
|
Sagent |
Ceftriaxone sodium |
EQ 10 gm base/vial; injection |
1/20/2017 |
|
Lupin |
Paroxetine |
EQ 12.5 mg base, EQ 25 mg base, and EQ 37.5 mg base; extended-release tablet |
1/20/2017 |
|
Macleods |
Tamsulosin HCl |
0.4 mg; capsule |
1/20/2017 |
|
DFB Oncology |
Docetaxel |
20 mg/mL, 80 mg/4 mL and 200 mg/10 mL; injection |
1/20/2017 |
|
Perrigo Israel |
Desoximetasone |
0.25%; topical spray |
1/20/2017 |
|
Aurobindo |
Dalfampridine |
10 mg; extended-release tablet |
1/23/2017 |
|
Actavis |
Dalfampridine |
10 mg; extended-release tablet |
1/23/2017 |
|
Sun |
Zolpidem tartrate |
6.25 mg and 12.5 mg; extended-release tablet |
1/24/2017 |
|
Par |
Phenoxybenzamine HCl |
10 mg; capsule |
1/24/2017 |
|
Tentative Approvals |
|||
|
Ohm Labs |
Sodium oxybate |
500 mg/mL; oral solution |
1/19/2017 |
|
Amneal |
Sodium oxybate |
500 mg/mL; oral solution |
1/19/2017 |