Application 208083
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE | SOLUTION;INTRAVENOUS | EQ 300MG BASE/50ML (EQ 6MG BASE/ML) | Yes | Yes |
| 002 | CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE | SOLUTION;INTRAVENOUS | EQ 600MG BASE/50ML (EQ 12MG BASE/ML) | Yes | Yes |
| 003 | CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE | SOLUTION;INTRAVENOUS | EQ 900MG BASE/50ML (EQ 18MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9545 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9549 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |
| 0338-9553 | clindamycin phosphate | clindamycin phosphate | Baxter Healthcare Corporation | NDA | Current |