APPLICATION
NDA050168
TYPE
NDA
ORIGINAL APPROVAL
1957-03-26
LATEST ACTION
2025-08-08
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
CORTISPORIN · ReferenceDiscontinued
BACITRACIN ZINC 400 UNITS/GM, HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
Approval history
2001-08-13Manufacturing (CMC) · Supplement 76AP
1999-07-19Labeling · Supplement 73 · standardAP
1999-05-28Manufacturing (CMC) · Supplement 75AP
1998-11-04Manufacturing (CMC) · Supplement 74AP
1993-09-22Manufacturing (CMC) · Supplement 9AP
1986-05-16Labeling · Supplement 5AP
1986-04-07Manufacturing (CMC) · Supplement 6AP
1985-12-04Labeling · Supplement 4AP
1984-06-25Labeling · Supplement 2AP
1983-07-06Manufacturing (CMC) · Supplement 1AP
1982-03-26Manufacturing (CMC) · Supplement 70AP
1981-10-20Manufacturing (CMC) · Supplement 69AP
1978-06-19Manufacturing (CMC) · Supplement 67AP
1977-05-06Manufacturing (CMC) · Supplement 66AP
1977-01-13Labeling · Supplement 65AP
1974-06-16Manufacturing (CMC) · Supplement 64AP
1974-04-24Labeling · Supplement 63AP
1974-02-12Manufacturing (CMC) · Supplement 62AP
1973-05-23Labeling · Supplement 56AP
1972-10-17Manufacturing (CMC) · Supplement 61AP
1972-10-16Labeling · Supplement 60AP
1972-07-05Labeling · Supplement 59AP
1972-06-23Labeling · Supplement 58AP
1971-05-10Manufacturing (CMC) · Supplement 57AP
1970-08-11Manufacturing (CMC) · Supplement 52AP
1970-07-24Labeling · Supplement 55AP
1970-06-15Labeling · Supplement 54AP
1970-05-25Labeling · Supplement 53AP
1970-04-17Labeling · Supplement 51AP
1970-04-07Labeling · Supplement 50AP
1969-07-08Labeling · Supplement 49AP
1969-03-04Manufacturing (CMC) · Supplement 47AP
1968-08-14Manufacturing (CMC) · Supplement 46AP
1968-07-02Labeling · Supplement 45AP
1967-12-18Labeling · Supplement 44AP
1967-08-11Labeling · Supplement 43AP
1967-07-20Labeling · Supplement 42AP
1967-07-20Labeling · Supplement 41AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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