Details for New Drug Application (NDA): 078147
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The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
Summary for 078147
Tradename: | ZALEPLON |
Applicant: | Hikma Pharms |
Ingredient: | zaleplon |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 25, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 25, 2008 | TE: | RLD: | No |
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