Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017710
Company: DISTA

Products on NDA 017710

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALFON	FENOPROFEN CALCIUM	EQ 600MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017710

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/1977	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
12/22/1997	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
04/25/1994	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/29/1995	SUPPL-21	Labeling		Label is not available on this site.
07/08/1987	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/04/1988	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
02/08/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/09/1986	SUPPL-12	Labeling		Label is not available on this site.
07/08/1987	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
03/31/1983	SUPPL-10	Labeling		Label is not available on this site.
12/11/1987	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/1983	SUPPL-7	Labeling		Label is not available on this site.
02/10/1982	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/10/1982	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/09/1983	SUPPL-4	Labeling		Label is not available on this site.
04/09/1980	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.