Product Details for NDA 212801
ISTURISA (OSILODROSTAT PHOSPHATE)
EQ 1MG BASE
Marketing Status: Prescription
EQ 5MG BASE
Marketing Status: Prescription
EQ 10MG BASE
Marketing Status: Discontinued
EQ 1MG BASE
Marketing Status: Prescription
Active Ingredient: OSILODROSTAT PHOSPHATE
Proprietary Name: ISTURISA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212801
Product Number: 001
Approval Date: Mar 6, 2020
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status: Prescription
Patent and Exclusivity Information
ISTURISA (OSILODROSTAT PHOSPHATE)
Proprietary Name: ISTURISA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212801
Product Number: 001
Approval Date: Mar 6, 2020
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: OSILODROSTAT PHOSPHATE
Proprietary Name: ISTURISA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212801
Product Number: 002
Approval Date: Mar 6, 2020
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status: Prescription
Patent and Exclusivity Information
ISTURISA (OSILODROSTAT PHOSPHATE)
Proprietary Name: ISTURISA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212801
Product Number: 002
Approval Date: Mar 6, 2020
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: OSILODROSTAT PHOSPHATE
Proprietary Name: ISTURISA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212801
Product Number: 003
Approval Date: Mar 6, 2020
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ISTURISA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N212801
Product Number: 003
Approval Date: Mar 6, 2020
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status: Discontinued
Patent and Exclusivity Information