Application 014134
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROTOPAM CHLORIDE | PRALIDOXIME CHLORIDE | INJECTABLE;INJECTION | 1GM/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60977-141 | Protopam Chloride | pralidoxime chloride | Baxter Healthcare Corporation | NDA | Current |
| 60977-141 | Protopam Chloride | pralidoxime chloride | Baxter Healthcare Corporation | NDA | Current |
| 60977-141 | Protopam Chloride | pralidoxime chloride | Baxter Healthcare Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 368 | SUPPL | 2010-09-13 |
| 10836 | SUPPL | 2010-09-10 |
| 33112 | SUPPL | 2002-09-27 |
| 12058 | SUPPL | 2002-09-27 |