Application 065294
- Type
- ANDA
- Sponsor
- CEPHAZONE PHARMA
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 |
|---|---|---|---|---|---|
| 68330-001 | Ceftriaxone | Ceftriaxone | Cephazone Pharma LLC | ANDA | Current |
| 68330-002 | Ceftriaxone | Ceftriaxone | Cephazone Pharma LLC | ANDA | Current |
| 68330-003 | Ceftriaxone | Ceftriaxone | Cephazone Pharma LLC | ANDA | Current |
| 68330-004 | Ceftriaxone | Ceftriaxone | Cephazone Pharma LLC | ANDA | Current |
| 68330-005 | Ceftriaxone | Ceftriaxone | Cephazone Pharma LLC | ANDA | Current |
| 68330-006 | Ceftriaxone | Ceftriaxone | Cephazone Pharma LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23745 | ORIG | 2008-09-19 |