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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200043

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ARMODAFINIL (ARMODAFINIL)
50MG
Marketing Status: Prescription
Active Ingredient: ARMODAFINIL
Proprietary Name: ARMODAFINIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200043
Product Number: 001
Approval Date: Jun 1, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ARMODAFINIL (ARMODAFINIL)
100MG
Marketing Status: Prescription
Active Ingredient: ARMODAFINIL
Proprietary Name: ARMODAFINIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200043
Product Number: 004
Approval Date: May 9, 2019
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ARMODAFINIL (ARMODAFINIL)
150MG
Marketing Status: Prescription
Active Ingredient: ARMODAFINIL
Proprietary Name: ARMODAFINIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200043
Product Number: 002
Approval Date: Jun 1, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ARMODAFINIL (ARMODAFINIL)
200MG
Marketing Status: Prescription
Active Ingredient: ARMODAFINIL
Proprietary Name: ARMODAFINIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200043
Product Number: 005
Approval Date: May 9, 2019
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ARMODAFINIL (ARMODAFINIL)
250MG
Marketing Status: Prescription
Active Ingredient: ARMODAFINIL
Proprietary Name: ARMODAFINIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200043
Product Number: 003
Approval Date: Jun 1, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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