Approved Drug Products containing 19116 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 19116

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 BUTYRATE, with a corresponding application number 19116.

Regulatory Information RX

With a dosage strength 0.1%

Dosage Form Route SOLUTION; TOPICAL

Reference Listed Drug Yes

Approved since 1987-02-25

Therapeutic Equivalence (TE) Code AT