Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205353

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FARYDAK (PANOBINOSTAT LACTATE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: PANOBINOSTAT LACTATE
Proprietary Name: FARYDAK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205353
Product Number: 001
Approval Date: Feb 23, 2015
Applicant Holder Full Name: SECURA BIO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FARYDAK (PANOBINOSTAT LACTATE)
EQ 15MG BASE
Marketing Status: Prescription
Active Ingredient: PANOBINOSTAT LACTATE
Proprietary Name: FARYDAK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205353
Product Number: 002
Approval Date: Feb 23, 2015
Applicant Holder Full Name: SECURA BIO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FARYDAK (PANOBINOSTAT LACTATE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: PANOBINOSTAT LACTATE
Proprietary Name: FARYDAK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205353
Product Number: 003
Approval Date: Feb 23, 2015
Applicant Holder Full Name: SECURA BIO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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