Details for New Drug Application (NDA): 211321

NDA 211321 describes NAYZILAM, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NAYZILAM profile page.

The generic ingredient in NAYZILAM is midazolam. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the midazolam profile page.

Summary for 211321

Tradename:	NAYZILAM
Applicant:	Ucb Inc
Ingredient:	midazolam
Patents:	4

Pharmacology for NDA: 211321

Suppliers and Packaging for NDA: 211321

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAYZILAM	midazolam	SPRAY;NASAL	211321	NDA	UCB, Inc.	50474-500	50474-500-15	2 BLISTER PACK in 1 CARTON (50474-500-15) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (50474-500-14) / .1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	5MG/SPRAY
Approval Date:	May 17, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 17, 2026
Regulatory Exclusivity Use:	ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER
Patent:		Patent Expiration:	Jan 18, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER
Patent:		Patent Expiration:	Jan 18, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

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