NAPROXEN SODIUM (nda021920)- (EQ 200MG BASE)

Generic Name	NAPROXEN SODIUM	Innovator	BIONPHARMA
Dosage	EQ 200MG BASE
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2026-Mar-03	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NAPROZEN SODIUM Tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • polyarticular juvenile idiopathic arthritis. NAPROZEN SODIUM Tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout. the management of: • pain • primary dysmenorrhea.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	3

Other Developers

Total Other Developers	27

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 200MG BASE	**	**	-	1	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of NAPROXEN SODIUM