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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: A208213
Product Number: 002
Approval Date: Apr 18, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status:
Prescription
Patent and Exclusivity Information
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: A208213
Product Number: 001
Approval Date: Nov 23, 2018
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status:
Prescription
Patent and Exclusivity Information