Details for New Drug Application (NDA): 207987
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NDA 207987 describes ABLYSINOL, which is a drug marketed by Bpi Labs and is included in one NDA. It is available from one supplier. 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. One supplier is 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. One supplier is listed for this compound. Additional details are available on the alcohol profile page.
Summary for 207987
| Tradename: | ABLYSINOL |
| Applicant: | Bpi Labs |
| Ingredient: | alcohol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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: | RX | 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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