Details for New Drug Application (NDA): 090543
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The generic ingredient in MODAFINIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 090543
Tradename: | MODAFINIL |
Applicant: | Hikma Pharms |
Ingredient: | modafinil |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 26, 2012 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Sep 26, 2012 | TE: | RLD: | No |
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