Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008693
Company: PROCTER AND GAMBLE

Products on NDA 008693

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008693

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.