FDA's ANDA Approvals
Executive Summary
Generic drug approvals and tentative approvals in early March.
|
Sponsor |
Active Ingredient |
Dosage; Formulation |
Approval Date |
|
Fresenius Kabi |
Magnesium sulfate in dextrose 5% in plastic container |
1 gm/100 mL; injection |
3/7/2016 |
|
Unichem |
Quetiapine fumarate |
EQ 25 mg base, EQ 50 mg base, EQ 100 mg base, EQ 200 mg base, EQ 300 mg base and EQ 400 mg base; tablet |
3/8/2016 |
|
Teva |
Budesonide |
1 mg/2 mL; inhalation suspension |
3/8/2016 |
|
Amneal |
Aspirin/dipyridamole |
25 mg/200 mg; extended-release capsule |
3/8/2016 |
|
Accord |
Ondansetron HCL preservative-free |
EQ 2 mg base/mL; injection |
3/10/2016 |
|
Aurobindo |
Ibandronate sodium |
EQ 150 mg; tablet |
3/11/2016 |
|
Glenmark |
Frovatriptan succinate |
EQ 2.5 mg base; tablet |
3/11/2016 |
|
Tris Pharma |
Gabapentin |
250 mg/5 mL; solution |
3/14/2016 |
|
Orchid |
Rasagiline mesylate |
EQ 0.5 mg base and EQ 1 mg base; tablet |
3/15/2016 |
|
Invagen |
Olanzapine |
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg; tablet |
3/15/2016 |
|
Fresenius Kabi |
Linezolid |
600 mg/300 mL (2 mg/mL); IV infusion |
3/15/2016 |
|
Tentative Approvals |
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|
Zydus |
Clofarabine |
20 mg/20 mL; injection |
3/4/2016 |
|
Appco Pharma |
Voriconazole |
50 mg and 200 mg; tablet |
3/16/2016 |