Product Details for NDA 202020
RAYOS (PREDNISONE)
1MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: RAYOS
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202020
Product Number: 001
Approval Date: Jul 26, 2012
Applicant Holder Full Name: HORIZON THERAPEUTICS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
RAYOS (PREDNISONE)
Proprietary Name: RAYOS
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202020
Product Number: 001
Approval Date: Jul 26, 2012
Applicant Holder Full Name: HORIZON THERAPEUTICS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
2MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: RAYOS
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202020
Product Number: 002
Approval Date: Jul 26, 2012
Applicant Holder Full Name: HORIZON THERAPEUTICS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
RAYOS (PREDNISONE)
Proprietary Name: RAYOS
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202020
Product Number: 002
Approval Date: Jul 26, 2012
Applicant Holder Full Name: HORIZON THERAPEUTICS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: RAYOS
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202020
Product Number: 003
Approval Date: Jul 26, 2012
Applicant Holder Full Name: HORIZON THERAPEUTICS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: RAYOS
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202020
Product Number: 003
Approval Date: Jul 26, 2012
Applicant Holder Full Name: HORIZON THERAPEUTICS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information