Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209408
Company: SAMSON MEDCL
Company: SAMSON MEDCL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 100GM BASE | POWDER;INTRAVENOUS | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/21/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209408Orig1s000ltr.pdf |