Details for New Drug Application (NDA): 207226
✉ Email this page to a colleague
NDA 207226 describes LEUCOVORIN CALCIUM, which is a drug marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, Gland, Hainan Poly, Hikma, Meitheal, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Fresenius Kabi Usa, Novast Labs, Ani Pharms, Barr, Epic Pharma Llc, Leading, Par Pharm, Xanodyne Pharm, Am Regent, Mylan Labs Ltd, Sagent Pharms, and Sagent Pharms Inc, and is included in forty-nine NDAs. It is available from fourteen suppliers. Additional details are available on the LEUCOVORIN CALCIUM profile page.
The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 207226
| Tradename: | LEUCOVORIN CALCIUM |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | leucovorin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207226
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | leucovorin calcium | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 207226 | ANDA | Fresenius Kabi USA, LLC | 63323-631 | 63323-631-50 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-631-50) / 50 mL in 1 VIAL, SINGLE-USE |
| LEUCOVORIN CALCIUM | leucovorin calcium | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 207226 | ANDA | Fresenius Kabi USA, LLC | 63323-631 | 63323-631-10 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-631-10) / 10 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 500MG BASE/50ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Jul 27, 2018 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
