Approved Drug Products containing 64135 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 64135

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 DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE, with a corresponding application number 64135.

Regulatory Information RX

With a dosage strength 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Dosage Form Route SUSPENSION/DROPS; OPHTHALMIC

Reference Listed Drug No

Approved since 1995-09-13

Therapeutic Equivalence (TE) Code AT