Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022522

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DALIRESP (ROFLUMILAST)
250MCG Marketing Status: Prescription

Active Ingredient: ROFLUMILAST
Proprietary Name: DALIRESP
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022522
Product Number: 002
Approval Date: Jan 23, 2018
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

DALIRESP (ROFLUMILAST)
500MCG Marketing Status: Prescription

Active Ingredient: ROFLUMILAST
Proprietary Name: DALIRESP
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MCG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022522
Product Number: 001
Approval Date: Feb 28, 2011
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

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