Details for New Drug Application (NDA): 090643
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NDA 090643 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 090643
| Tradename: | IBUTILIDE FUMARATE |
| Applicant: | Mylan Institutional |
| Ingredient: | ibutilide fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090643
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUTILIDE FUMARATE | ibutilide fumarate | INJECTABLE;INJECTION | 090643 | ANDA | Mylan Institutional LLC | 67457-366 | 67457-366-10 | 1 VIAL, GLASS in 1 CARTON (67457-366-10) / 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: | Jan 11, 2010 | TE: | AP | RLD: | No | ||||
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