Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018267
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUROSEMIDE | FUROSEMIDE | 10MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 05/19/1981 | 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 |
|---|---|---|---|---|---|
| 05/10/2023 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018267s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018267Orig1s027ltr.pdf | |
| 08/29/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/18/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/05/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/05/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/17/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/14/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/03/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1984 | 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 |
|---|---|---|---|---|---|
| 05/10/2023 | SUPPL-27 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018267s027lbl.pdf |