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Generated: November 17, 2018

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Details for New Drug Application (NDA): 207987

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NDA 207987 describes ABLYSINOL, which is a drug marketed by Belcher Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the ABLYSINOL profile page.

The generic ingredient in ABLYSINOL is alcohol. There are forty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alcohol profile page.
Summary for 207987
Tradename:ABLYSINOL
Applicant:Belcher Pharms Llc
Ingredient:alcohol
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207987
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABLYSINOL alcohol SOLUTION;INTRA-ARTERIAL 207987 NDA BPI Labs, LLC 54288-105 54288-105-10 10 AMPULE in 1 CARTON (54288-105-10) > 1 mL in 1 AMPULE (54288-105-01)
ABLYSINOL alcohol SOLUTION;INTRA-ARTERIAL 207987 NDA BPI Labs, LLC 54288-105 54288-105-15 10 AMPULE in 1 CARTON (54288-105-15) > 5 mL in 1 AMPULE (54288-105-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRA-ARTERIALStrength99% (1ML)
Approval Date:Jun 21, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 21, 2025
Regulatory Exclusivity Use:INDICATED TO INDUCE CONTROLLED CARDIAC SEPTAL INFRACTION TO IMPROVE EXERCISE CAPACITY IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WHO ARE NOT CANDIDATES FOR SURGICAL MYECTOMY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRA-ARTERIALStrength99% (5ML)
Approval Date:Jun 21, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 21, 2025
Regulatory Exclusivity Use:INDICATED TO INDUCE CONTROLLED CARDIAC SEPTAL INFRACTION TO IMPROVE EXERCISE CAPACITY IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WHO ARE NOT CANDIDATES FOR SURGICAL MYECTOMY

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