Details for New Drug Application (NDA): 213929
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The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 213929
Tradename: | LEUCOVORIN CALCIUM |
Applicant: | Leading |
Ingredient: | leucovorin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213929
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 213929 | ANDA | Leading Pharma, LLC | 69315-184 | 69315-184-01 | 100 TABLET in 1 BOTTLE (69315-184-01) |
LEUCOVORIN CALCIUM | leucovorin calcium | TABLET;ORAL | 213929 | ANDA | Leading Pharma, LLC | 69315-184 | 69315-184-03 | 30 TABLET in 1 BOTTLE (69315-184-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Oct 22, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Oct 22, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
Approval Date: | Oct 22, 2020 | TE: | AB | RLD: | No |
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