Application 079183
- Type
- ANDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-0187 | GEMCITABINE | GEMCITABINE | Hospira, Inc. | ANDA | Current |
| 0409-0187 | GEMCITABINE | GEMCITABINE | Hospira, Inc. | ANDA | Current |
| 0409-0187 | GEMCITABINE | GEMCITABINE | Hospira, Inc. | ANDA | Current |
| 0409-0187 | GEMCITABINE | GEMCITABINE | Hospira, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31423 | ORIG | 2009-02-24 |