Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011323
Company: SHIRE
Company: SHIRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUROXONE | FURAZOLIDONE | 50MG/15ML | SUSPENSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/20/1958 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/15/1999 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/03/1987 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/20/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/20/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |