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Generated: January 23, 2019

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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 two suppliers. There are nine 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-six 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:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 208437
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 208437
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 Holopack Verpackungstechnik GmbH 60940-024 60940-024-01 432 POUCH in 1 CARTON (60940-024-01) > 2 VIAL in 1 POUCH > 1 mL in 1 VIAL
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength25MCG/ML
Approval Date:Dec 5, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 5, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Oct 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 6, 2022Product Flag?YSubstance Flag?Delist Request?

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