Details for New Drug Application (NDA): 217021
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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 217021
Tradename: | LEUCOVORIN CALCIUM |
Applicant: | Hainan Poly |
Ingredient: | leucovorin calcium |
Patents: | 0 |
Suppliers and Packaging for NDA: 217021
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM | leucovorin calcium | INJECTABLE;INJECTION | 217021 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-116 | 70436-116-82 | 10 VIAL in 1 BOX (70436-116-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-116-80) |
LEUCOVORIN CALCIUM | leucovorin calcium | INJECTABLE;INJECTION | 217021 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-117 | 70436-117-80 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-117-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/VIAL | ||||
Approval Date: | Jul 10, 2023 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
Approval Date: | Jul 10, 2023 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
Approval Date: | Jul 10, 2023 | TE: | AP | RLD: | No |
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