← FDA DRUG APPROVALS

FDA NDA · NDA050356

CORTISPORIN TC

colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate

Sponsor: PH HEALTH

APPLICATION
NDA050356
TYPE
NDA
ORIGINAL APPROVAL
1962-05-17
LATEST ACTION
2019-01-05
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

COLY-MYCIN S · ReferencePrescription
COLISTIN SULFATE EQ 3MG BASE/ML, HYDROCORTISONE ACETATE 10MG/ML, NEOMYCIN SULFATE EQ 3.3MG BASE/ML, THONZONIUM BROMIDE 0.5MG/ML · SUSPENSION/DROPS · OTIC

Approval history

2019-01-05Labeling · Supplement 59 · standard — Label ↗AP
2016-03-29Manufacturing (CMC) · Supplement 56AP
2013-12-06Manufacturing (CMC) · Supplement 55AP
2009-06-02Labeling · Supplement 50 · standard — Label ↗AP
2002-03-01Labeling · Supplement 45 · standard — Letter ↗AP
2001-12-05Manufacturing (CMC) · Supplement 48AP
2001-09-27Manufacturing (CMC) · Supplement 47AP
1997-04-23Manufacturing (CMC) · Supplement 46AP
1997-01-08Labeling · Supplement 43 · standardAP
1994-08-02Manufacturing (CMC) · Supplement 44AP
1991-07-01Manufacturing (CMC) · Supplement 6AP
1986-03-17Manufacturing (CMC) · Supplement 5AP
1985-12-17Manufacturing (CMC) · Supplement 4AP
1984-03-23Manufacturing (CMC) · Supplement 3AP
1983-09-13Manufacturing (CMC) · Supplement 2AP
1982-12-28Manufacturing (CMC) · Supplement 1AP
1982-08-03Manufacturing (CMC) · Supplement 42AP
1982-03-18Manufacturing (CMC) · Supplement 40AP
1982-03-05Manufacturing (CMC) · Supplement 41AP
1981-10-19Manufacturing (CMC) · Supplement 39AP
1980-10-15Labeling · Supplement 38AP
1979-10-17Labeling · Supplement 37AP
1978-07-19Manufacturing (CMC) · Supplement 36AP
1976-11-18Manufacturing (CMC) · Supplement 35AP
1972-10-16Labeling · Supplement 34AP
1968-11-20Manufacturing (CMC) · Supplement 32AP
1967-11-24Manufacturing (CMC) · Supplement 31AP
1967-07-17Manufacturing (CMC) · Supplement 30AP
1967-07-14Labeling · Supplement 29AP
1967-04-18Labeling · Supplement 28AP
1967-03-08Labeling · Supplement 27AP
1967-01-31Labeling · Supplement 26AP
1967-01-31Labeling · Supplement 25AP
1966-12-30Manufacturing (CMC) · Supplement 22AP
1966-12-21Labeling · Supplement 24AP
1966-10-31Manufacturing (CMC) · Supplement 23AP
1966-05-20Manufacturing (CMC) · Supplement 21AP
1966-04-22Labeling · Supplement 20AP
1966-01-07Manufacturing (CMC) · Supplement 18AP
1965-12-14Manufacturing (CMC) · Supplement 16AP
VIEW ON DRUGS@FDA ↗

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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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