Application 209077
- Type
- ANDA
- Sponsor
- SAGENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/5.26ML (38MG/ML) | No | No |
| 002 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1GM/26.3ML (38MG/ML) | No | No |
| 003 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | 2GM/52.6ML (38MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-239 | Gemcitabine | gemcitabine | Sagent Pharmaceuticals | ANDA | Current |