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Application 065369
- Type
- ANDA
- Sponsor
- HOSPIRA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 003 | CEFEPIME HYDROCHLORIDE | CEFEPIME 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 |
|---|
| 60505-6030 | Cefepime | CEFEPIME | Apotex Corporation | ANDA | Current |
| 60505-6031 | Cefepime | CEFEPIME | Apotex Corporation | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 30658 | ORIG | 2007-07-23 |
| 42816 | ORIG | 2007-06-18 |