Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021875

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NUVIGIL (ARMODAFINIL)
50MG Marketing Status: Prescription

Active Ingredient: ARMODAFINIL
Proprietary Name: NUVIGIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021875
Product Number: 001
Approval Date: Jun 15, 2007
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NUVIGIL (ARMODAFINIL)
150MG Marketing Status: Prescription

Active Ingredient: ARMODAFINIL
Proprietary Name: NUVIGIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021875
Product Number: 003
Approval Date: Jun 15, 2007
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NUVIGIL (ARMODAFINIL)
200MG Marketing Status: Prescription

Active Ingredient: ARMODAFINIL
Proprietary Name: NUVIGIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021875
Product Number: 005
Approval Date: Mar 26, 2009
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NUVIGIL (ARMODAFINIL)
250MG Marketing Status: Prescription

Active Ingredient: ARMODAFINIL
Proprietary Name: NUVIGIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021875
Product Number: 004
Approval Date: Jun 15, 2007
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NUVIGIL (ARMODAFINIL)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ARMODAFINIL
Proprietary Name: NUVIGIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021875
Product Number: 002
Approval Date: Mar 26, 2009
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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