Pathocil

NDA 50011, held by Wyeth Ayerst. Dicloxacillin Sodium.

As of Nov 14, 2026, NDA 50011 (Pathocil), held by Wyeth Ayerst, was first approved by FDA on May 9, 1968, with 29 approved supplements and 0 published complete response letters.

First approved: May 9, 1968
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Aug 12, 1985	Supplement 2Efficacy (new indication or use)	Approved	None posted
May 9, 1968	Original application	Approved	None posted

Products

2 strengths and forms


PathocilEQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Dicloxacillin Sodium	DiscontinuedReference drug
PathocilEQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Dicloxacillin Sodium	DiscontinuedReference drug

All 30 submissions, including labeling and manufacturing supplements


Apr 10, 1991	Supplement 4Manufacturing	Approved	None posted
Jan 16, 1987	Supplement 3Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 2Efficacy (new indication or use)	Approved	None posted
Mar 28, 1983	Supplement 1Manufacturing	Approved	None posted
Feb 28, 1983	Supplement 29Manufacturing	Approved	None posted
Oct 28, 1982	Supplement 28Manufacturing	Approved	None posted
Apr 26, 1982	Supplement 27Manufacturing	Approved	None posted
Oct 23, 1981	Supplement 26Manufacturing	Approved	None posted
Oct 14, 1980	Supplement 25Manufacturing	Approved	None posted
Oct 2, 1980	Supplement 24Labeling	Approved	None posted
Sep 19, 1980	Supplement 23Labeling	Approved	None posted
Apr 24, 1978	Supplement 22Manufacturing	Approved	None posted
Jan 11, 1977	Supplement 21Labeling	Approved	None posted
Jan 27, 1976	Supplement 20Labeling	Approved	None posted
Aug 15, 1975	Supplement 19Labeling	Approved	None posted
May 30, 1975	Supplement 18Labeling	Approved	None posted
Apr 11, 1974	Supplement 17Labeling	Approved	None posted
Apr 1, 1974	Supplement 16Labeling	Approved	None posted
Mar 20, 1974	Supplement 15Labeling	Approved	None posted
Feb 22, 1974	Supplement 14Labeling	Approved	None posted
Feb 22, 1974	Supplement 13Manufacturing	Approved	None posted
Oct 5, 1973	Supplement 12Labeling	Approved	None posted
Mar 2, 1973	Supplement 11Labeling	Approved	None posted
Aug 1, 1972	Supplement 10Labeling	Approved	None posted
Dec 14, 1970	Supplement 9Manufacturing	Approved	None posted
Sep 1, 1970	Supplement 8Labeling	Approved	None posted
Sep 26, 1969	Supplement 7Labeling	Approved	None posted
Jul 1, 1968	Supplement 6Labeling	Approved	None posted
Jun 5, 1968	Supplement 5Manufacturing	Approved	None posted
May 9, 1968	Original application	Approved	None posted

Identifiers

Application: NDA 50011
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters