Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202020

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RAYOS (PREDNISONE)
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 PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RAYOS (PREDNISONE)
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 PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RAYOS (PREDNISONE)
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 PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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