FDA's ANDA Approvals

Generic drug approvals in early and mid-December.

Sponsor	Active Ingredient	Dosage; Formulation	Approval Date
Antibiotics SA	Ampicillin/sulbactam ampicillin sodium	EQ 1 gm base/vial/EQ 500 mg base/vial and EQ 2 gm base/vial/ EQ 1 gm base/vial; injection	12/7/2015
Pharmaceutics	Potassium Cl	8 mEQ and 10 mEQ; extended-release capsule	12/8/2015
Aurobindo	Eptifibatide	2 mg/mL and 75 g mg/100 mL; injection	12/8/2015
MacLeods	Risedronate sodium	5 mg and 30 mg; tablet	12/9/2015
Fresenius Kabi	Amikacin sulfate	EQ 250 mg base/mL; injection	12/9/2015
Fresenius Kabi	Amikacin sulfate	EQ 50 mg base/mL; injection	12/9/2015
Novel Labs	Diclofenac sodium	1.5%; topical solution	12/9/2015
Akorn	Cyclopentolate HCl	0.5%; ophthalmic solution/drops	12/9/2015
Antares	Sumatriptan succinate	EQ 4 mg/0.5 mL and EQ 6 mg base/0.5 mL; subcutaneous injectable	12/10/2015
Ajanta	Irbesartan	75 mg and 150 mg; tablet	12/10/2015
Lupin	Fyavolv (ethinyl estradiol/norethindrone acetate)	0.0025 mg/0.5 mg and 0.005 mg/1 mg; tablet	12/10/2015
Alkem	Fesoterodine fumarate	4 mg and 8 mg; extended-release tablet	12/10/2015
Ascent	Amlodipine besylate	EQ 2.5 mg base and EQ 10 mg base; tablet	12/10/2015
Hospira	Oxacillin sodium	EQ 1 gm base/vial and EQ 2 gm base/vial; injection	12/11/2015
Amneal	Niacin	750 mg; extended-release tablet	12/11/2015
Alvogen	Nateglinide	60 mg and 120 mg; tablet	12/11/2015
Epic	Benzphetamine HCl	50 mg; tablet	12/15/2015
Hetero Labs	Citalopram HCl	EQ 10 mg base/5 mL; oral solution	12/15/2015
Aurobindo	Methylprednisolone sodium succinate	EQ 40 mg base/vial, EQ 125 mg base/vial, EQ 500 mg base/vial and EQ 2 gm base/vial; injectable	12/15/2015
Orion	Buspirone HCl	5 mg, 10 mg, 15 mg and 30 mg; tablet	12/16/2015
Secan	Levetiracetam	250 mg, 750 mg and 1 gm; tablet	12/16/2015