Details for New Drug Application (NDA): 021412
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NDA 021412 describes TOVALT ODT, which is a drug marketed by Biovail Labs Intl and is included in one NDA. Additional details are available on the TOVALT ODT profile page.
The generic ingredient in TOVALT ODT is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
The generic ingredient in TOVALT ODT is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 021412
| Tradename: | TOVALT ODT |
| Applicant: | Biovail Labs Intl |
| Ingredient: | zolpidem tartrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 25, 2007 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 25, 2007 | TE: | RLD: | Yes | |||||
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