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COLY-MYCIN S

NDA · New Drug Application · Sponsor: PH HEALTH · Approved 1962-05-17

Drug application

FDA Application #
NDA050356
Application type
New Drug Application
Brand name
COLY-MYCIN S
Generic name
COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE
Active ingredients
COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE
Dosage form
SUSPENSION/DROPS
Route
OTIC
Marketing status
Prescription
Sponsor
PH HEALTH
Manufacturer
Endo USA, Inc.
First approval
1962-05-17

Source

Authoritative
Drugs@FDA application overview
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