Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065141
Company: SAMSON MEDCL
Company: SAMSON MEDCL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 100GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | No | Yes |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 300GM BASE/VIAL | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
11/29/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/28/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
09/28/2018 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
07/30/2013 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065141s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/065141Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/30/2013 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065141s003lbl.pdf |