Pathocil

NDA 50092, held by Wyeth Ayerst. Dicloxacillin Sodium.

As of Nov 14, 2026, NDA 50092 (Pathocil), held by Wyeth Ayerst, was first approved by FDA on Apr 22, 1968, with 29 approved supplements and 0 published complete response letters.

First approved: Apr 22, 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

Date	Submission	Status	Documents
Apr 22, 1968	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
PathocilEQ 62.5MG BASE/5ML · for suspension;oral	Dicloxacillin Sodium	Discontinued

All 30 submissions, including labeling and manufacturing supplements


Apr 10, 1991	Supplement 4Labeling	Approved	None posted
Jan 9, 1986	Supplement 3Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 2Labeling	Approved	None posted
Sep 5, 1984	Supplement 1Manufacturing	Approved	None posted
Oct 22, 1980	Supplement 32Labeling	Approved	None posted
Aug 26, 1980	Supplement 31Labeling	Approved	None posted
Nov 2, 1976	Supplement 30Manufacturing	Approved	None posted
Oct 15, 1976	Supplement 29Manufacturing	Approved	None posted
Sep 23, 1976	Supplement 28Labeling	Approved	None posted
Mar 25, 1976	Supplement 27Labeling	Approved	None posted
Aug 15, 1975	Supplement 26Labeling	Approved	None posted
May 30, 1975	Supplement 25Labeling	Approved	None posted
Apr 18, 1974	Supplement 24Labeling	Approved	None posted
Apr 11, 1974	Supplement 23Manufacturing	Approved	None posted
Apr 1, 1974	Supplement 22Labeling	Approved	None posted
Jan 14, 1974	Supplement 21Manufacturing	Approved	None posted
Nov 27, 1973	Supplement 20Labeling	Approved	None posted
Nov 14, 1973	Supplement 19Manufacturing	Approved	None posted
Jul 29, 1971	Supplement 18Manufacturing	Approved	None posted
Apr 14, 1971	Supplement 17Labeling	Approved	None posted
Aug 11, 1970	Supplement 15Manufacturing	Approved	None posted
Nov 26, 1969	Supplement 14Labeling	Approved	None posted
Nov 26, 1969	Supplement 13Manufacturing	Approved	None posted
Nov 13, 1969	Supplement 12Labeling	Approved	None posted
Jun 3, 1969	Supplement 11Labeling	Approved	None posted
May 27, 1969	Supplement 10Labeling	Approved	None posted
Dec 20, 1968	Supplement 8Labeling	Approved	None posted
Nov 19, 1968	Supplement 7Labeling	Approved	None posted
Jul 12, 1968	Supplement 5Manufacturing	Approved	None posted
Apr 22, 1968	Original application	Approved	None posted

Identifiers

Application: NDA 50092
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