Details for New Drug Application (NDA): 019151
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NDA 019151 describes RYTHMOL, which is a drug marketed by Glaxosmithkline Llc and is included in two NDAs. Additional details are available on the RYTHMOL profile page.
The generic ingredient in RYTHMOL is propafenone hydrochloride. There are eleven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
The generic ingredient in RYTHMOL is propafenone hydrochloride. There are eleven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 019151
| Tradename: | RYTHMOL |
| Applicant: | Glaxosmithkline Llc |
| Ingredient: | propafenone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019151
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 27, 1989 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 27, 1989 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 20, 1992 | TE: | RLD: | Yes | |||||
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