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Application 050779
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Yes | Yes |
| 003 | CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Yes | No |
| 004 | CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 3GM BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0264-3103 | Cefazolin Sodium | Cefazolin Sodium | B. Braun Medical Inc. | NDA | Current |
| 0264-3103 | Cefazolin Sodium | Cefazolin Sodium | B. Braun Medical Inc. | NDA | Current |
| 0264-3103 | Cefazolin Sodium | Cefazolin Sodium | B. Braun Medical Inc. | NDA | Current |
| 0264-3105 | Cefazolin Sodium | Cefazolin Sodium | B. Braun Medical Inc. | NDA | Current |
| 0264-3105 | Cefazolin Sodium | Cefazolin Sodium | B. Braun Medical Inc. | NDA | Current |
| 0264-3105 | Cefazolin Sodium | Cefazolin Sodium | B. Braun Medical Inc. | NDA | Current |