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Details for New Drug Application (NDA): 207923

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NDA 207923 describes SEEBRI, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the SEEBRI profile page.

The generic ingredient in SEEBRI is glycopyrrolate. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for NDA: 207923

Novartis Pharms Corp
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 207923

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 207923

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POWDER;INHALATION 207923 NDA Novartis Pharmaceuticals Corporation 0078-0662 0078-0662-19 60 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0662-19) > 1 CAPSULE in 1 BLISTER PACK (0078-0662-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength15.6MCG/INH
Approval Date:Oct 29, 2015TE:RLD:Yes
Patent:6,521,260Patent Expiration:Jan 31, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,582,678Patent Expiration:Apr 24, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:7,736,670Patent Expiration:Jun 27, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 207923

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
POWDER;INHALATION207923-001Oct 29, 20156,521,260► subscribe
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