TOBI PODHALER (nda201688)- (28MG)

Generic Name	TOBRAMYCIN	Innovator	MYLAN SPECIALITY LP
Dosage	28MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2030-Nov-04	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2016-Mar-22
GAIN Expiry	None	Drug Complexity	No
Indication	TOBI Podhaler is an aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
28MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TOBI PODHALER