Details for New Drug Application (NDA): 207987
✉ Email this page to a colleague
NDA 207987 describes ABLYSINOL, which is a drug marketed by Bpi Labs 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. Eight suppliers are listed for this compound. Additional details are available on the alcohol profile page.
The generic ingredient in ABLYSINOL is alcohol. There are forty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the alcohol profile page.
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| SOLUTION;INTRA-ARTERIAL | Strength | 99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| 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: | AP | 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 | ||||||||
Complete Access Available with Subscription
