Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POLYMYXIN B SULFATE | POLYMYXIN B SULFATE | EQ 500,000 UNITS BASE/VIAL | INJECTABLE;INJECTION | Discontinued | 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 |
---|---|---|---|---|---|---|---|
06/29/1964 | 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 |
---|---|---|---|---|---|
03/29/2019 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
01/30/2012 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716Orig1s020Lbl.pdf | |
01/27/2012 | SUPPL-18 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716s018lbl.pdf | |
05/15/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/28/2000 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/28/2000 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
11/28/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/31/1996 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/26/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
08/26/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/26/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/17/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/03/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/30/2012 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716Orig1s020Lbl.pdf | |
01/27/2012 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716s018lbl.pdf |