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 two suppliers. Additional details are available on the ABLYSINOL profile page.
The generic ingredient in ABLYSINOL is dehydrated alcohol. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the dehydrated alcohol profile page.
The generic ingredient in ABLYSINOL is dehydrated alcohol. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the dehydrated alcohol profile page.
Summary for 207987
| Tradename: | ABLYSINOL |
| Applicant: | Bpi Labs |
| Ingredient: | dehydrated alcohol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207987
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABLYSINOL | dehydrated 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 | dehydrated 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| SOLUTION;INTRA-ARTERIAL | Strength | 99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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 | ||||
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