Approved Drug Products containing 9175 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 9175

DELCOR ASSET, based in U.S.A, is a pharmaceutical company.

One of their notable products is NITROFURANTOIN, with a corresponding application number 9175.

Regulatory Information RX

With a dosage strength 25MG/5ML

Dosage Form Route SUSPENSION; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

Therapeutic Equivalence (TE) Code AB

score 19 · Accepted Answer

DELCOR ASSET, based in U.S.A, is a pharmaceutical company.

One of their notable products is NITROFURANTOIN, with a corresponding application number 9175.

Regulatory Information RX

With a dosage strength 50MG/5ML

Dosage Form Route SUSPENSION; ORAL

Reference Listed Drug Yes

Approved since 2023-06-09