Application 209816

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUZYRA	OMADACYCLINE TOSYLATE	TABLET;ORAL	EQ 150MG BASE	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71715-002	NUZYRA	omadacycline	Paratek Pharmaceuticals, Inc.	NDA	Current
71715-002	NUZYRA	omadacycline	Paratek Pharmaceuticals, Inc.	NDA	Current
71715-002	NUZYRA	omadacycline	Paratek Pharmaceuticals, Inc.	NDA	Current
71715-002	NUZYRA	omadacycline	Paratek Pharmaceuticals, Inc.	NDA	Current
71715-002	NUZYRA	omadacycline	Paratek Pharmaceuticals, Inc.	NDA	Current
71715-002	NUZYRA	omadacycline	Paratek Pharmaceuticals, Inc.	NDA	Current
71715-002	NUZYRA	omadacycline	Paratek Pharmaceuticals, Inc.	NDA	Current