Details for New Drug Application (NDA): 010598
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NDA 010598 describes BENDECTIN, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the BENDECTIN profile page.
The generic ingredient in BENDECTIN is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
The generic ingredient in BENDECTIN is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
Summary for 010598
| Tradename: | BENDECTIN |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | doxylamine succinate; pyridoxine hydrochloride |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No | |||||
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