Product Details for ANDA 212396
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
EQ 40MG BASE/VIAL
Marketing Status: Prescription
EQ 125MG BASE/VIAL
Marketing Status: Prescription
EQ 500MG BASE/VIAL
Marketing Status: Prescription
EQ 1GM BASE/VIAL
Marketing Status: Prescription
EQ 2GM BASE/VIAL
Marketing Status: Prescription
EQ 40MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 40MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 001
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 40MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 001
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 125MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 125MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 002
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 125MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 002
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 500MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 003
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 003
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 1GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 004
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 004
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 2GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 005
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212396
Product Number: 005
Approval Date: Apr 20, 2021
Applicant Holder Full Name: TIANJIN KINGYORK PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information