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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020717

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PROVIGIL (MODAFINIL)
100MG
Marketing Status: Prescription
Active Ingredient: MODAFINIL
Proprietary Name: PROVIGIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020717
Product Number: 001
Approval Date: Dec 24, 1998
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PROVIGIL (MODAFINIL)
200MG
Marketing Status: Prescription
Active Ingredient: MODAFINIL
Proprietary Name: PROVIGIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020717
Product Number: 002
Approval Date: Dec 24, 1998
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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