Application 018016
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 450MG/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0043 | Sodium Chloride | Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0043 | Sodium Chloride | Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0043 | Sodium Chloride | Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0043 | Sodium Chloride | Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0043 | Sodium Chloride | Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0043 | Sodium Chloride | Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0043 | Sodium Chloride | Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79226 | SUPPL | 2024-07-29 |
| 79214 | SUPPL | 2024-07-25 |
| 58967 | SUPPL | 2019-06-04 |
| 58892 | SUPPL | 2019-05-30 |
| 11119 | SUPPL | 2015-01-08 |
| 784 | SUPPL | 2014-12-30 |
| 11118 | SUPPL | 2013-09-17 |
| 783 | SUPPL | 2013-09-13 |
| 11117 | SUPPL | 2005-08-31 |
| 782 | SUPPL | 2005-08-31 |
| 13980 | SUPPL | 2005-05-25 |
| 11116 | SUPPL | 2005-05-25 |
| 781 | SUPPL | 2003-07-28 |
| 780 | SUPPL | 2002-04-03 |