Details for New Drug Application (NDA): 211003
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The generic ingredient in LEVOLEUCOVORIN CALCIUM is levoleucovorin calcium. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 211003
Tradename: | LEVOLEUCOVORIN CALCIUM |
Applicant: | Meitheal |
Ingredient: | levoleucovorin calcium |
Patents: | 0 |
Suppliers and Packaging for NDA: 211003
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | POWDER;INTRAVENOUS | 211003 | ANDA | Meitheal Pharmaceuticals Inc | 71288-104 | 71288-104-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-104-10) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
Approval Date: | Aug 22, 2019 | TE: | AP | RLD: | No |
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