Details for New Drug Application (NDA): 021416
✉ Email this page to a colleague
The generic ingredient in RYTHMOL SR is propafenone hydrochloride. There are eleven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 021416
Tradename: | RYTHMOL SR |
Applicant: | Glaxosmithkline Llc |
Ingredient: | propafenone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021416
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416 | NDA | GlaxoSmithKline LLC | 0173-0823 | 0173-0823-18 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0173-0823-18) |
RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416 | NDA | GlaxoSmithKline LLC | 0173-0824 | 0173-0824-18 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0173-0824-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 225MG | ||||
Approval Date: | Sep 4, 2003 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 325MG | ||||
Approval Date: | Sep 4, 2003 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 425MG | ||||
Approval Date: | Sep 4, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 021416
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416-001 | Sep 4, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline Llc | RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416-002 | Sep 4, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline Llc | RYTHMOL SR | propafenone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021416-003 | Sep 4, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription