DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 078095
The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
Summary for 078095
Tradename: | ZALEPLON |
Applicant: | Upsher-smith Labs |
Ingredient: | zaleplon |
Patents: | 0 |
Therapeutic Class: | Sedatives/Hypnotics |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 6, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 6, 2008 | TE: | RLD: | No |
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