Application 040266
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-122 | Methotrexate | METHOTREXATE SODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-122 | Methotrexate | METHOTREXATE SODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-122 | Methotrexate | METHOTREXATE SODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 17760 | ORIG | 2004-06-09 |
| 22111 | ORIG | 2003-07-31 |
| 7597 | ORIG | 1999-02-26 |