GLYRX-PF (nda210997)- (0.2MG/ML (0.2MG/ML),0.4MG/2ML (0.2MG/ML),0.6MG/3ML (0.2MG/ML),1MG/5ML (0.2MG/ML))

Generic Name	GLYCOPYRROLATE	Innovator	EXELA PHARMA
Dosage	0.2MG/ML (0.2MG/ML),0.4MG/2ML (0.2MG/ML),0.6MG/3ML (0.2MG/ML),1MG/5ML (0.2MG/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	GLYRX- PF is an anticholinergic indicated: 1. In anesthesia (adult and pediatric patients)  for reduction of airway or gastric secretions, and volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation,  intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and  for protection against peripheral muscarinic effects of cholinergic agents. 2. In peptic ulcer (adults)  as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.2MG/ML (0.2MG/ML)	**	**	-	-	-
0.4MG/2ML (0.2MG/ML)	**	**	-	-	-
0.6MG/3ML (0.2MG/ML)	**	**	-	-	-
1MG/5ML (0.2MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of GLYRX-PF