Product Details for NDA 205353
FARYDAK (PANOBINOSTAT LACTATE)
EQ 10MG BASE
Marketing Status: Discontinued
EQ 15MG BASE
Marketing Status: Discontinued
EQ 20MG BASE
Marketing Status: Discontinued
EQ 10MG BASE
Marketing Status: Discontinued
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: Discontinued
Patent and Exclusivity Information
FARYDAK (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: Discontinued
Patent and Exclusivity Information
EQ 15MG BASE
Marketing Status: Discontinued
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: Discontinued
Patent and Exclusivity Information
FARYDAK (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: Discontinued
Patent and Exclusivity Information
EQ 20MG BASE
Marketing Status: Discontinued
Active Ingredient: PANOBINOSTAT LACTATE
Proprietary Name: FARYDAK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N205353
Product Number: 003
Approval Date: Feb 23, 2015
Applicant Holder Full Name: SECURA BIO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FARYDAK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N205353
Product Number: 003
Approval Date: Feb 23, 2015
Applicant Holder Full Name: SECURA BIO INC
Marketing Status: Discontinued
Patent and Exclusivity Information