DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077238
The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
Summary for 077238
Tradename: | ZALEPLON |
Applicant: | Mylan |
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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