Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050092
Company: WYETH AYERST

Products on NDA 050092

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PATHOCIL	DICLOXACILLIN SODIUM	EQ 62.5MG BASE/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050092

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/1968	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/1980	SUPPL-32	Labeling		Label is not available on this site.
08/26/1980	SUPPL-31	Labeling		Label is not available on this site.
11/02/1976	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/1976	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
09/23/1976	SUPPL-28	Labeling		Label is not available on this site.
03/25/1976	SUPPL-27	Labeling		Label is not available on this site.
08/15/1975	SUPPL-26	Labeling		Label is not available on this site.
05/30/1975	SUPPL-25	Labeling		Label is not available on this site.
04/18/1974	SUPPL-24	Labeling		Label is not available on this site.
04/11/1974	SUPPL-23	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/01/1974	SUPPL-22	Labeling		Label is not available on this site.
01/14/1974	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/27/1973	SUPPL-20	Labeling		Label is not available on this site.
11/14/1973	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/29/1971	SUPPL-18	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/14/1971	SUPPL-17	Labeling		Label is not available on this site.
08/11/1970	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/26/1969	SUPPL-14	Labeling		Label is not available on this site.
11/26/1969	SUPPL-13	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/13/1969	SUPPL-12	Labeling		Label is not available on this site.
06/03/1969	SUPPL-11	Labeling		Label is not available on this site.
05/27/1969	SUPPL-10	Labeling		Label is not available on this site.
12/20/1968	SUPPL-8	Labeling		Label is not available on this site.
11/19/1968	SUPPL-7	Labeling		Label is not available on this site.
07/12/1968	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/10/1991	SUPPL-4	Labeling		Label is not available on this site.
01/09/1986	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/12/1985	SUPPL-2	Labeling		Label is not available on this site.
09/05/1984	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.