Details for New Drug Application (NDA): 016647
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NDA 016647 describes QUINAGLUTE, which is a drug marketed by Bayer Hlthcare and is included in one NDA. Additional details are available on the QUINAGLUTE profile page.
The generic ingredient in QUINAGLUTE is quinidine gluconate. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the quinidine gluconate profile page.
The generic ingredient in QUINAGLUTE is quinidine gluconate. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the quinidine gluconate profile page.
Summary for 016647
| Tradename: | QUINAGLUTE |
| Applicant: | Bayer Hlthcare |
| Ingredient: | quinidine gluconate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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