Details for New Drug Application (NDA): 022425
✉ Email this page to a colleague
NDA 022425 describes MULTAQ, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MULTAQ profile page.
The generic ingredient in MULTAQ is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.
The generic ingredient in MULTAQ is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.
Summary for 022425
| Tradename: | MULTAQ |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | dronedarone hydrochloride |
| Patents: | 3 |
Pharmacology for NDA: 022425
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors |
Suppliers and Packaging for NDA: 022425
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MULTAQ | dronedarone hydrochloride | TABLET;ORAL | 022425 | NDA | Sanofi-Aventis U.S. LLC | 0024-4142 | 0024-4142-00 | 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) |
| MULTAQ | dronedarone hydrochloride | TABLET;ORAL | 022425 | NDA | Sanofi-Aventis U.S. LLC | 0024-4142 | 0024-4142-06 | 8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Jul 1, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 16, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 16, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jun 30, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF RISK OF DRONEDARONE/BETA-BLOCKER INTERACTION IN PATIENTS IN SINUS RHYTHM WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF | ||||||||
Expired US Patents for NDA 022425
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | MULTAQ | dronedarone hydrochloride | TABLET;ORAL | 022425-001 | Jul 1, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Sanofi Aventis Us | MULTAQ | dronedarone hydrochloride | TABLET;ORAL | 022425-001 | Jul 1, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Sanofi Aventis Us | MULTAQ | dronedarone hydrochloride | TABLET;ORAL | 022425-001 | Jul 1, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
