Details for New Drug Application (NDA): 021412
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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 |
Formulation / Manufacturing: | see details |
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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