Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011270
Company: SHIRE
Company: SHIRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUROXONE | FURAZOLIDONE | 100MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/21/1961 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/1990 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/18/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1986 | SUPPL-16 | Labeling |
Label is not available on this site. |