Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008693
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.

03/27/1997 SUPPL-29 Labeling

Label is not available on this site.

02/17/1998 SUPPL-28 Labeling

Label is not available on this site.

08/09/1993 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1998 SUPPL-26 Labeling

Label is not available on this site.

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.

05/18/1993 SUPPL-20 Efficacy-New Indication

Label is not available on this site.

11/18/1982 SUPPL-19 Labeling

Label is not available on this site.

06/29/1979 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/17/1979 SUPPL-16 Labeling

Label is not available on this site.

03/16/1979 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/11/1976 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/30/1976 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

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