Application 204957
- Type
- NDA
- Sponsor
- B BRAUN MEDICAL INC
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 | 500MG/50ML?(10MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0264-4050 | Acetaminophen | Acetaminophen | B. Braun Medical Inc. | NDA | Current |
| 0264-4050 | Acetaminophen | Acetaminophen | B. Braun Medical Inc. | NDA | Current |
| 0264-4050 | Acetaminophen | Acetaminophen | B. Braun Medical Inc. | NDA | Current |
| 0264-4050 | Acetaminophen | Acetaminophen | B. Braun Medical Inc. | NDA | Current |
| 0264-4100 | Acetaminophen | Acetaminophen | B. Braun Medical Inc. | NDA | Current |
| 0264-4100 | Acetaminophen | Acetaminophen | B. Braun Medical Inc. | NDA | Current |
| 0264-4100 | Acetaminophen | Acetaminophen | B. Braun Medical Inc. | NDA | Current |
| 0264-4100 | Acetaminophen | Acetaminophen | B. Braun Medical Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68511 | ORIG | 2021-09-01 |
| 66301 | ORIG | 2021-02-22 |
| 66302 | ORIG | 2021-02-19 |