Application 214331
- Type
- ANDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ACETAMINOPHEN | ACETAMINOPHEN | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | No | No |
| 002 | ACETAMINOPHEN | ACETAMINOPHEN | SOLUTION;INTRAVENOUS | 650MG/65ML (10MG/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 36000-306 | Acetaminophen | Acetaminophen | Baxter Healthcare Corporation | ANDA | Current |
| 36000-306 | Acetaminophen | Acetaminophen | Baxter Healthcare Corporation | ANDA | Current |
| 36000-306 | Acetaminophen | Acetaminophen | Baxter Healthcare Corporation | ANDA | Current |
| 36000-306 | Acetaminophen | Acetaminophen | Baxter Healthcare Corporation | ANDA | Current |