Details for New Drug Application (NDA): 207987
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The generic ingredient in ABLYSINOL is alcohol. There are forty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alcohol profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207987
Generic Entry Date for 207987*:
Constraining patent/regulatory exclusivity:
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 Dosage:
SOLUTION;INTRA-ARTERIAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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: | DISCN | Dosage: | SOLUTION;INTRA-ARTERIAL | Strength | 99% (1ML) | ||||
Approval Date: | Jun 21, 2018 | TE: | 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: | RX | Dosage: | SOLUTION;INTRA-ARTERIAL | Strength | 99% (5ML) | ||||
Approval Date: | Jun 21, 2018 | TE: | 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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