Details for New Drug Application (NDA): 209110
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The generic ingredient in LEUCOVORIN CALCIUM PRESERVATIVE FREE 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 209110
Tradename: | LEUCOVORIN CALCIUM PRESERVATIVE FREE |
Applicant: | Sagent Pharms Inc |
Ingredient: | leucovorin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209110
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM PRESERVATIVE FREE | leucovorin calcium | INJECTABLE;INJECTION | 209110 | ANDA | Sagent Pharmaceuticals | 25021-828 | 25021-828-50 | 1 VIAL in 1 CARTON (25021-828-50) / 50 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Oct 26, 2017 | TE: | AP | RLD: | No |
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