Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208684

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EMFLAZA (DEFLAZACORT)
6MG
Marketing Status: Prescription

Active Ingredient: DEFLAZACORT
Proprietary Name: EMFLAZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N208684
Product Number: 001
Approval Date: Feb 9, 2017
Applicant Holder Full Name: PTC THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EMFLAZA (DEFLAZACORT)
18MG
Marketing Status: Prescription

Active Ingredient: DEFLAZACORT
Proprietary Name: EMFLAZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 18MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N208684
Product Number: 002
Approval Date: Feb 9, 2017
Applicant Holder Full Name: PTC THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EMFLAZA (DEFLAZACORT)
30MG
Marketing Status: Prescription

Active Ingredient: DEFLAZACORT
Proprietary Name: EMFLAZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N208684
Product Number: 003
Approval Date: Feb 9, 2017
Applicant Holder Full Name: PTC THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EMFLAZA (DEFLAZACORT)
36MG
Marketing Status: Prescription

Active Ingredient: DEFLAZACORT
Proprietary Name: EMFLAZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 36MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N208684
Product Number: 004
Approval Date: Feb 9, 2017
Applicant Holder Full Name: PTC THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information