Application 090799
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL | No | No |
| 002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-102 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-102 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-102 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-102 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-102 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-102 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-102 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-125 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-125 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-125 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-125 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-125 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-125 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-125 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-126 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-126 | GEMCITABINE | GEMCITABINE | Fresenius Kabi USA, LLC | ANDA | Current |