Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005795
Company: SHIRE
Company: SHIRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FURACIN | NITROFURAZONE | 0.2% | OINTMENT;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/04/1945 | 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 |
|---|---|---|---|---|---|
| 02/09/2000 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/21/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/21/1998 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/09/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/1982 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/12/1984 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/17/1982 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 09/12/1980 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/11/1979 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/12/1978 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |