Product Details for ANDA 213929
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
EQ 5MG BASE
Marketing Status: Prescription
EQ 10MG BASE
Marketing Status: Prescription
EQ 15MG BASE
Marketing Status: Prescription
EQ 25MG BASE
Marketing Status: Prescription
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213929
Product Number: 001
Approval Date: Oct 22, 2020
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213929
Product Number: 001
Approval Date: Oct 22, 2020
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213929
Product Number: 002
Approval Date: Oct 22, 2020
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213929
Product Number: 002
Approval Date: Oct 22, 2020
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 15MG BASE
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213929
Product Number: 003
Approval Date: Oct 22, 2020
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213929
Product Number: 003
Approval Date: Oct 22, 2020
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: LEUCOVORIN CALCIUM
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213929
Product Number: 004
Approval Date: Oct 22, 2020
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LEUCOVORIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213929
Product Number: 004
Approval Date: Oct 22, 2020
Applicant Holder Full Name: LEADING PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information