Product Details for ANDA 216590
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
EQ 50MG BASE/VIAL
Marketing Status: Prescription
EQ 100MG BASE/VIAL
Marketing Status: Prescription
EQ 200MG BASE/VIAL
Marketing Status: Prescription
EQ 350MG BASE/VIAL
Marketing Status: Prescription
EQ 500MG BASE/VIAL
Marketing Status: Prescription
EQ 50MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 001
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 001
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 002
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 002
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 200MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 200MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 003
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 200MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 003
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 350MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 350MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 004
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 350MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 004
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 500MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 005
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216590
Product Number: 005
Approval Date: Jul 19, 2023
Applicant Holder Full Name: KINDOS PHARMACEUTICALS CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information