Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211734

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APREMILAST (APREMILAST)
10MG
Marketing Status: Prescription

Active Ingredient: APREMILAST
Proprietary Name: APREMILAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211734
Product Number: 001
Approval Date: Feb 7, 2024
Applicant Holder Full Name: MANKIND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

APREMILAST (APREMILAST)
20MG
Marketing Status: Prescription

Active Ingredient: APREMILAST
Proprietary Name: APREMILAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211734
Product Number: 002
Approval Date: Feb 7, 2024
Applicant Holder Full Name: MANKIND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

APREMILAST (APREMILAST)
30MG
Marketing Status: Prescription

Active Ingredient: APREMILAST
Proprietary Name: APREMILAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211734
Product Number: 003
Approval Date: Feb 7, 2024
Applicant Holder Full Name: MANKIND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information