Details for New Drug Application (NDA): 204146
✉ Email this page to a colleague
NDA 204146 describes IBUTILIDE FUMARATE, which is a drug marketed by Avet Lifesciences, Luitpold, and Mylan Institutional, and is included in four NDAs. It is available from two suppliers. Additional details are available on the IBUTILIDE FUMARATE profile page.
The generic ingredient in IBUTILIDE FUMARATE is ibutilide fumarate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibutilide fumarate profile page.
The generic ingredient in IBUTILIDE FUMARATE is ibutilide fumarate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibutilide fumarate profile page.
Summary for 204146
| Tradename: | IBUTILIDE FUMARATE |
| Applicant: | Avet Lifesciences |
| Ingredient: | ibutilide fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204146
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUTILIDE FUMARATE | ibutilide fumarate | INJECTABLE;INJECTION | 204146 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-326 | 23155-326-31 | 1 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.1MG/ML | ||||
| Approval Date: | Apr 1, 2024 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
