FDA's ANDA Approvals

Sponsor	Active Ingredient	Dosage; Formulation	Approval Date
Glenmark	Desmopressin acetate	0.1 mg and 0.2 mg; tablet	5/28/2015
Lupin	Moxifloxacin HCl	EQ 0.5% base; ophthalmic solution/drops	5/28/2015
Novel Labs	Doxycycline	EQ 50 mg base, EQ 75 mg base, and EQ 100 mg base; capsule	5/28/2015
Vintage	Clindamycin phosphate	EQ 1% base; topical solution	5/29/2015
Amneal	Divalproex sodium	EQ 250 mg and EQ 500 mg; extended-release tablet	5/29/2015
Xellia	Colistimethate sodium	EQ 150 mg base/vial; injection	5/29/2015
Par	Amlodipine besylate/hydrochlorothiazide/ valsartan	5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/12.5 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg; tablet	6/1/2015
Sagent	Chlorothiazide sodium	EQ 500 mg base/vial; injection	6/1/2015
Ani	Oxycodone HCl	5 mg/5 mL; oral solution	6/1/2015
Teva	Guanfacine HCl	EQ 1 mg base, EQ 2 mg base, EQ 3 mg base and EQ 4 mg base; extended-release tablet	6/2/2015
TWI	Guanfacine HCl	EQ 1 mg base, EQ 2 mg base, EQ 3 mg base and EQ 4 mg base; extended-release tablet	6/2/2015
Mylan	Guanfacine HCl	EQ 1 mg base, EQ 2 mg base, EQ 3 mg base and EQ 4 mg base; extended-release tablet	6/2/2015
Apotex	Celecoxib	50 mg, 100 mg and 200 mg; capsule	6/2/2015
Roxane	Linezolid	100 mg/5 mL; oral suspension	6/3/2015
Lupin	Amlodipine besylate/hydrochlorothiazide/ valsartan	5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/12.5 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg; tablet	6/3/2015
Tentative Approvals
Watson	Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium	3 mg/0.03 mg/0.451 mg and 0.451 mg; tablet	5/28/2015
Novel Labs	Sodium sulfate/potassium sulfate/magnesium sulfate	15.5 g/13 g/1.6 g; oral solution	5/28/2015
Watson	Solifenacin succinate	5 mg and 10 mg; tablet	6/2/2015