Application 091089
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31515 | ORIG | 2010-12-03 |