Application 065391
- Type
- ANDA
- Sponsor
- WOCKHARDT
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 2GM BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42254-152 | CEFTRIAXONE | CEFTRIAXONE | Rebel Distributors Corp | ANDA | Current |
| 42254-191 | CEFTRIAXONE | CEFTRIAXONE | Rebel Distributors Corp | ANDA | Current |
| 55648-701 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt Limited | ANDA | Current |
| 55648-702 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt Limited | ANDA | Current |
| 55648-703 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt Limited | ANDA | Current |
| 64679-701 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
| 64679-701 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
| 64679-701 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
| 64679-702 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
| 64679-702 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
| 64679-702 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
| 64679-703 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
| 64679-703 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
| 64679-703 | CEFTRIAXONE | CEFTRIAXONE | Wockhardt USA LLC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44236 | ORIG | 2008-09-19 |