Approved Drug Products containing 64053 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 64053

score 19 · Accepted Answer

Bausch & Lomb Incorporated, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE, with a corresponding application number 64053.

Regulatory Information RX

With a dosage strength 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Dosage Form Route SOLUTION/DROPS; OTIC

Reference Listed Drug No

Approved since 1995-12-29

Therapeutic Equivalence (TE) Code AT