Drugs@FDA: FDA-Approved Drugs
Company: PROCTER AND GAMBLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FURADANTIN | NITROFURANTOIN | 50MG | TABLET;ORAL | Discontinued | None | No | No |
FURADANTIN | NITROFURANTOIN | 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 |
---|---|---|---|---|---|---|---|
02/06/1953 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/16/1997 | SUPPL-30 | Labeling |
Label is not available on this site. |
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03/27/1997 | SUPPL-29 | Labeling |
Label is not available on this site. |
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02/17/1998 | SUPPL-28 | Labeling |
Label is not available on this site. |
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08/09/1993 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/17/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
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05/13/1988 | SUPPL-25 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm |
07/14/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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05/18/1993 | SUPPL-20 | Efficacy-New Indication |
Label is not available on this site. |
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11/18/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
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06/29/1979 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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12/17/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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03/16/1979 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/11/1976 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1976 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |