Details for New Drug Application (NDA): 040147
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NDA 040147 describes LEUCOVORIN CALCIUM PRESERVATIVE FREE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Sagent Pharms, Sagent Pharms Inc, Hospira, and Teva Parenteral, and is included in twelve NDAs. It is available from five suppliers. Additional details are available on the LEUCOVORIN CALCIUM PRESERVATIVE FREE profile page.
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.
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 040147
| Tradename: | LEUCOVORIN CALCIUM PRESERVATIVE FREE |
| Applicant: | Hospira |
| Ingredient: | leucovorin calcium |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 040147
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 100MG BASE/10ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 25, 1997 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Jun 25, 1997 | TE: | RLD: | No | |||||
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