Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 065430
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER | CEFOTETAN DISODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER | CEFOTETAN DISODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
08/09/2007 | ORIG-1 | Approval | UNKNOWN |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065430ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/30/2020 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/065430s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/065430Orig1s009ltr.pdf | |
12/18/2013 | SUPPL-6 | Manufacturing (CMC) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/30/2020 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/065430s009lbl.pdf |