Details for New Drug Application (NDA): 078179
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The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 078179
Tradename: | ZOLPIDEM TARTRATE |
Applicant: | Actavis Elizabeth |
Ingredient: | zolpidem tartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 12.5MG | ||||
Approval Date: | Jun 6, 2011 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6.25MG | ||||
Approval Date: | Oct 13, 2010 | TE: | RLD: | No |
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