Details for New Drug Application (NDA): 203800
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NDA 203800 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 203800
| Tradename: | LEUCOVORIN CALCIUM PRESERVATIVE FREE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | leucovorin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203800
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | leucovorin calcium | INJECTABLE;INJECTION | 203800 | ANDA | Mylan Institutional LLC | 67457-528 | 67457-528-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-528-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | leucovorin calcium | INJECTABLE;INJECTION | 203800 | ANDA | Mylan Institutional LLC | 67457-529 | 67457-529-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-529-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | May 19, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
| Approval Date: | May 19, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 350MG BASE/VIAL | ||||
| Approval Date: | May 19, 2017 | TE: | AP | RLD: | No | ||||
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