FDA’s ANDA Approvals

Applicant	Active Ingredients	Number	Date Approved
Hikma	Gabapentin, 600 mg & 800 mg tabs.	78-782	7/21/2011
Marksans	Gabapentin, 100 mg, 300 mg & 400 mg caps.	90-007	7/21/2011
Tolmar	Metronidazole 1% gel	90-903	7/21/2011
West-ward	Fludrocortisone acetate,1 mg tab	91-302	7/22/2011
Lupin	Mefenamic acid 250mg caps.	91-322	7/22/2011
Apotex	Famciclovir,125 mg, 250 mg & 500 mg tabs	91-480	7/22/2011
Hospira	Gemcitabine HCl, EQ 200mg,1gm base/vial, inj.	78-339	7/25/2011
Sun Global	Gemcitabine HCl, EQ 200mg,1gm base/vial, inj.	78-433	7/25/2011
Watson	Gemcitabine HCl EQ 200mg,1gm base/vial, inj.	78-759	7/25/2011
Actavis totowa	Gemcitabine HCl EQ 200mg,1gm base/vial, inj.	79-160	7/25/2011
Dr Reddys Labs	Gemcitabine HCl EQ 200mg,1gm base/vial, inj.	91-365	7/25/2011
Accord Hlthcare	Gemcitabine HCl EQ 200mg,1gm, 2gm base/vial, inj.	91-594	7/25/2011
Onco Therapies	Gemcitabine HCl EQ 200mg,1gm, 2gm base/vial, inj.	200-145	7/25/2011
Sun Global	Chlorothiazide HCl EQ 500mg base/vial, inj.	91-546	7/26/2011
Tentative Approvals
Emcure	Zoledronic acid, 4 mg/5 mL inj.	201-783	7/21/2011
Torrent	Escitalopram oxalate, 5 mg tabs.	90-939	7/22/2011
Dr Reddys Labs	Duloxetine HCl,20mg,30mg,60mg tabs.	90-723	7/22/2011