Chart: FDA's ANDA Approvals

FDA's ANDA Approvals
Applicant	Active Ingredients	Number	Date Approved
Perrigo	Cetirizine HCl syrup, 1 mg/mL (Rx only)	78-398	6/17/2008
OHM	Metoprolol tartrate USP, 25 mg, 50 mg and 100 mg tabs.	78-459	6/17/2008
Hospira	Hydromorphone HCl USP, 10 mg/mL; packaged in 10 mg/1 mL, 50 mg/5 mL and 500 mg/50 mL single-use vials inj.	78-591	6/17/2008
Teva	Ramipril, 1.25 mg, 2.5 mg, 5 mg and 10 mg caps.	77-470	6/18/2008
Ranbaxy	Cetirizine HCl syrup, 1 mg/mL (Rx only)	77-472	6/18/2008
Actavis	Ramipril, 1.25 mg, 2.5 mg, 5 mg and 10 mg caps.	77-513	6/18/2008
Sandoz	Ramipril, 1.25 mg, 2.5 mg, 5 mg and 10 mg caps.	77-514	6/18/2008
Roxane	Ramipril, 1.25 mg, 2.5 mg, 5 mg and 10 mg caps.	77-900	6/18/2008
Dr. Reddy's	Ramipril, 1.25 mg, 2.5 mg, 5 mg and 10 mg caps.	78-191	6/18/2008
Apotex	Cetirizine HCl syrup, 1 mg/mL (Rx only)	78-412	6/18/2008
Glenmark	Trandolapril, 1 mg, 2 mg and 4 mg tabs.	78-508	6/18/2008
Invagen	Ramipril, 1.25 mg, 2.5 mg, 5 mg and 10 mg caps.	78-745	6/18/2008
Tentative Approvals
Roxane	Buprenorphine HCl sublingual, 2 mg (base) and 8 mg (base) tabs.	78-633	6/18/2008