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Details for New Drug Application (NDA): 208294

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NDA 208294 describes BEVESPI AEROSPHERE, which is a drug marketed by Pearl Theraps Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the BEVESPI AEROSPHERE profile page.

The generic ingredient in BEVESPI AEROSPHERE is formoterol fumarate; glycopyrrolate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; glycopyrrolate profile page.

Summary for NDA: 208294

Tradename:
BEVESPI AEROSPHERE
Applicant:
Pearl Theraps Inc
Ingredient:
formoterol fumarate; glycopyrrolate
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 208294

Suppliers and Packaging for NDA: 208294

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BEVESPI AEROSPHERE
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION 208294 NDA AstraZeneca Pharmaceuticals LP 0310-4600 0310-4600-12 120 AEROSOL, METERED in 1 INHALER (0310-4600-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.0048MG/INH;0.0090MG/INH
Approval Date:Apr 25, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 25, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:8,324,266Patent Expiration:May 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN THE LONG-TERM, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:8,703,806Patent Expiration:May 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN THE LONG-TERM, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)


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