Application 065328
- Type
- ANDA
- Sponsor
- ACS DOBFAR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9768 | Ceftriaxone | Ceftriaxone | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9768 | Ceftriaxone | Ceftriaxone | West-Ward Pharmaceutical Corp | ANDA | Current |
| 25021-108 | Ceftriaxone | Ceftriaxone Sodium | Sagent Pharmaceuticals | ANDA | Current |
| 25021-108 | Ceftriaxone | Ceftriaxone Sodium | Sagent Pharmaceuticals | ANDA | Current |
| 25021-108 | Ceftriaxone | Ceftriaxone Sodium | Sagent Pharmaceuticals | ANDA | Current |
| 25021-108 | Ceftriaxone | Ceftriaxone Sodium | Sagent Pharmaceuticals | ANDA | Current |
| 25021-108 | Ceftriaxone | Ceftriaxone Sodium | Sagent Pharmaceuticals | ANDA | Current |
| 25021-108 | Ceftriaxone | Ceftriaxone Sodium | Sagent Pharmaceuticals | ANDA | Current |
| 25021-108 | Ceftriaxone | Ceftriaxone Sodium | Sagent Pharmaceuticals | ANDA | Current |
| 25021-108 | Ceftriaxone | Ceftriaxone Sodium | Sagent Pharmaceuticals | ANDA | Current |
| 44567-703 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-703 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-703 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-703 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-703 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-703 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 63323-348 | Ceftriaxone | Ceftriaxone | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44231 | ORIG | 2008-09-19 |