Application 074983
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ETOPOSIDE | ETOPOSIDE | INJECTABLE;INJECTION | 20MG/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-104 | Etoposide | ETOPOSIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-104 | Etoposide | ETOPOSIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-104 | Etoposide | ETOPOSIDE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 30728 | ORIG | 1998-09-30 |
| 22399 | ORIG | 1998-09-30 |