Application 040286
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-711 | Leucovorin Calcium | LEUCOVORIN CALCIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-711 | Leucovorin Calcium | LEUCOVORIN CALCIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-711 | Leucovorin Calcium | LEUCOVORIN CALCIUM | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42610 | ORIG | 2002-01-17 |
| 29914 | ORIG | 1999-02-26 |