Application 065230
- Type
- ANDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 250MG BASE/VIAL | No | No |
| 002 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 500MG BASE/VIAL | No | No |
| 003 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 1GM BASE/VIAL | No | No |
| 004 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 2GM BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-202 | Ceftriaxone Sodium | Ceftriaxone Sodium | Rebel Distributors Corp | ANDA | Current |
| 21695-352 | Ceftriaxone Sodium | Ceftriaxone Sodium | Rebel Distributors Corp | ANDA | Current |
| 50090-0943 | Ceftriaxone | Ceftriaxone | A-S Medication Solutions | ANDA | Current |
| 60505-0750 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0750 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0750 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0751 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0751 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0751 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0752 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0752 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0752 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0753 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0753 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 60505-0753 | Ceftriaxone | Ceftriaxone | Apotex Corporation | ANDA | Current |
| 70518-0601 | Ceftriaxone | Ceftriaxone | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23740 | ORIG | 2008-09-19 |