Application 202253
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 76045-103 | ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-103 | ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-103 | ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-103 | ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-103 | ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-216 | ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-216 | ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |