Application 204767
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-434 | Acetaminophen | ACETAMINOPHEN | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-434 | Acetaminophen | ACETAMINOPHEN | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-434 | Acetaminophen | ACETAMINOPHEN | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68222 | SUPPL | 2021-07-29 |
| 67913 | SUPPL | 2021-06-28 |
| 67899 | SUPPL | 2021-06-25 |
| 65231 | SUPPL | 2020-11-16 |
| 65225 | SUPPL | 2020-11-16 |
| 22964 | ORIG | 2016-07-19 |
| 10390 | ORIG | 2015-10-30 |
| 19594 | ORIG | 2015-10-29 |