Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200938
Company: SAMSON MEDCL
Company: SAMSON MEDCL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFOXITIN IN PLASTIC CONTAINER | CEFOXITIN SODIUM | EQ 100GM BASE | POWDER;INTRAVENOUS | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/16/2015 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200938Orig1s000ltr.pdf |