Product Details for ANDA 204867
PREDNISONE (PREDNISONE)
1MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204867
Product Number: 001
Approval Date: Apr 25, 2017
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status: Prescription
Patent and Exclusivity Information
PREDNISONE (PREDNISONE)
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204867
Product Number: 001
Approval Date: Apr 25, 2017
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status: Prescription
Patent and Exclusivity Information
2MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204867
Product Number: 002
Approval Date: Apr 25, 2017
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status: Prescription
Patent and Exclusivity Information
PREDNISONE (PREDNISONE)
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204867
Product Number: 002
Approval Date: Apr 25, 2017
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204867
Product Number: 003
Approval Date: Apr 25, 2017
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204867
Product Number: 003
Approval Date: Apr 25, 2017
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status: Prescription
Patent and Exclusivity Information