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Details for New Drug Application (NDA): 207930

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NDA 207930 describes UTIBRON, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the UTIBRON profile page.

The generic ingredient in UTIBRON is glycopyrrolate ; indacaterol maleate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrrolate ; indacaterol maleate profile page.

Summary for NDA: 207930

Sunovion Pharms Inc
glycopyrrolate ; indacaterol maleate
Formulation / Manufacturing:see details

Pharmacology for NDA: 207930

Suppliers and Packaging for NDA: 207930

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION 207930 NDA Novartis Pharmaceuticals Corporation 0078-0664 0078-0664-06 6 CAPSULE in 1 BOX, UNIT-DOSE (0078-0664-06)
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION 207930 NDA Novartis Pharmaceuticals Corporation 0078-0664 0078-0664-19 60 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0664-19) > 1 CAPSULE in 1 BLISTER PACK (0078-0664-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength15.6MCG/INH;27.5MCG/INH
Approval Date:Oct 29, 2015TE:RLD:Yes
Patent:7,736,670Patent Expiration:Jun 27, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,048,451Patent Expiration:Jun 27, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,182,838Patent Expiration:Oct 20, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 207930

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 20156,521,260► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.