Application 209408
- Type
- ANDA
- Sponsor
- SAMSON MEDCL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER | CEFEPIME HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 100GM BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66288-8100 | CEFEPIME | CEFEPIME | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA | Current |
| 66288-8100 | CEFEPIME | CEFEPIME | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA | Current |
| 66288-8100 | CEFEPIME | CEFEPIME | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA | Current |
| 66288-8100 | CEFEPIME | CEFEPIME | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55406 | ORIG | 2018-09-07 |