Product Details for ANDA 211575
PREDNISONE (PREDNISONE)
2.5MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
2.5MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 001
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
PREDNISONE (PREDNISONE)
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 001
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 002
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
PREDNISONE (PREDNISONE)
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 002
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 003
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
PREDNISONE (PREDNISONE)
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 003
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 004
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
PREDNISONE (PREDNISONE)
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 004
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 005
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211575
Product Number: 005
Approval Date: Nov 15, 2019
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information