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Application 211413
- Type
- NDA
- Sponsor
- HQ SPCLT PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | POWDER;INTRAVENOUS | EQ 2GM BASE/VIAL | Yes | Yes |
| 002 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | POWDER;INTRAVENOUS | EQ 3GM BASE/VIAL | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85073 | SUPPL | 2026-02-18 |
| 85052 | SUPPL | 2026-02-18 |
| 82338 | SUPPL | 2025-05-28 |
| 78303 | ORIG | 2024-04-30 |
| 74197 | ORIG | 2023-05-09 |
| 74190 | ORIG | 2023-05-09 |