FDA's ANDA Approvals
Executive Summary
US generic drug approvals and tentative approvals for mid-February.
|
Sponsor |
Active Ingredient |
Dosage; Formulation |
Approval Date |
|
Atlas |
Methocarbamol |
500 mg and 750 mg; tablet |
2/8/2017 |
|
Accord |
Carboplatin |
500 mg/5 mL (10 mg/mL), 150 mg/15 mL (10 mg/mL), 450 mg/45 mL (10 mg/mL), and 600 mg/60 mL (10 mg/mL); injectable, IV infusion |
2/9/2017 |
|
Mylan |
Estradiol/ norethindrone acetate |
0.5 mg/0.1 mg and 1 mg/0.5 mg; tablet
|
2/10/2017 |
|
Gland |
Oxaliplatin |
50 mg/10 mL (5 mg/mL) and 100 mg/20 mL (5 mg/mL); injectable, IV infusion |
2/10/2017 |
|
Cipla |
Oxaliplatin |
50 mg/10 mL (5 mg/mL) and 100 mg/20 mL (5 mg/mL); injectable, IV infusion |
2/10/2017 |
|
Novel |
Homatropine methylbromide/ hydrocodone bitartrate |
1.5 mg/5 ml and 5 mg/5 mL; syrup
|
2/13/2017 |
|
Cadila |
Rivastigmine tartrate |
EQ 1.5 mg base, EQ 3 mg base, EQ 4.5 mg base and EQ 6 mg base; capsule |
2/13/2017 |
|
Actavis |
Levoleucovorin calcium |
EQ 50 mg base/vial; powder, IV infusion |
2/13/2017 |
|
Amneal |
Levoleucovorin calcium |
EQ 50 mg base/vial; powder, IV infusion |
2/13/2017 |
|
Gland |
Tranexamic acid |
100 mg/mL; injection |
2/13/2017 |
|
Novel |
Moxifloxacin HCl |
EQ 400 mg base; tablet |
2/13/2017 |
|
Teva |
Logilia (ulipristal acetate) |
30 mg; tablet |
2/13/2017 |
|
Mylan |
Zoldedronic acid |
EQ 5 mg base/100 mL; injectable, IV infusion |
2/14/2017 |
|
Tentative Approvals |
|||
|
Mylan |
Bivalirudin |
250 mg/vial; injectable |
2/10/2017 |
|
Sun |
Tadalafil |
2.5 mg, 5 mg, 10 mg and 20 mg; tablet |
2/10/2017 |