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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208256

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ROFLUMILAST (ROFLUMILAST)
250MCG
Marketing Status: Prescription
Active Ingredient: ROFLUMILAST
Proprietary Name: ROFLUMILAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208256
Product Number: 001
Approval Date: Sep 7, 2022
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ROFLUMILAST (ROFLUMILAST)
500MCG
Marketing Status: Prescription
Active Ingredient: ROFLUMILAST
Proprietary Name: ROFLUMILAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208256
Product Number: 002
Approval Date: Sep 7, 2022
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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