Details for New Drug Application (NDA): 208437

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NDA 208437 describes LONHALA MAGNAIR KIT, which is a drug marketed by Sunovion Resp and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the LONHALA MAGNAIR KIT profile page.

The generic ingredient in LONHALA MAGNAIR KIT is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 208437

Tradename:	LONHALA MAGNAIR KIT
Applicant:	Sunovion Resp
Ingredient:	glycopyrrolate
Patents:	13
Formulation / Manufacturing:	see details

Pharmacology for NDA: 208437

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 208437

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 208437

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437	NDA	Sunovion Pharmaceuticals Inc.	63402-201	63402-201-00	1 CARTON in 1 KIT (63402-201-00) > 30 POUCH in 1 CARTON > 2 VIAL, SINGLE-DOSE in 1 POUCH > 1 mL in 1 VIAL, SINGLE-DOSE
LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437	NDA	Sunovion Pharmaceuticals Inc.	63402-301	63402-301-01	1 CARTON in 1 KIT (63402-301-01) > 30 POUCH in 1 CARTON > 2 VIAL, SINGLE-DOSE in 1 POUCH > 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	25MCG/ML
Approval Date:	Dec 5, 2017	TE:		RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	Sep 14, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	See Plans and Pricing	Patent Expiration:	Nov 12, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	See Plans and Pricing	Patent Expiration:	Dec 7, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF USING AN AEROSOL DELIVERY DEVICE TO AEROSOLIZE GLYCOPYRROLATE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Expired US Patents for NDA 208437

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sunovion Resp	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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