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Application 065168
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-7334 | Ceftriaxone Sodium | Ceftriaxone Sodium | Hospira, Inc | ANDA | Current |
| 0409-7334 | Ceftriaxone Sodium | Ceftriaxone Sodium | Hospira, Inc | ANDA | Current |
| 0409-7334 | Ceftriaxone Sodium | Ceftriaxone Sodium | Hospira, Inc | ANDA | Current |
| 0409-7334 | Ceftriaxone Sodium | Ceftriaxone Sodium | Hospira, Inc | ANDA | Current |
| 0409-7334 | Ceftriaxone Sodium | Ceftriaxone Sodium | Hospira, Inc | ANDA | Current |
| 0409-7334 | Ceftriaxone Sodium | Ceftriaxone Sodium | Hospira, Inc | ANDA | Current |
| 0781-3210 | Ceftriaxone Sodium | Ceftriaxone Sodium | Sandoz Inc | ANDA | Current |
| 0781-3210 | Ceftriaxone Sodium | Ceftriaxone Sodium | Sandoz Inc | ANDA | Current |
| 0781-3210 | Ceftriaxone Sodium | Ceftriaxone Sodium | Sandoz Inc | ANDA | Current |
| 0781-3210 | Ceftriaxone Sodium | Ceftriaxone Sodium | Sandoz Inc | ANDA | Current |
| 43858-635 | Ceftriaxone Sodium | Ceftriaxone Sodium | Sandoz GmbH | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 18332 | SUPPL | 2014-02-04 |
| 44214 | ORIG | 2008-09-19 |