Approved Drug Products containing 20908 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 20908

Novo Nordisk, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTRADIOL, with a corresponding application number 20908.

Regulatory Information RX

With a dosage strength 10MCG

Dosage Form Route TABLET; VAGINAL

Reference Listed Drug Yes

Approved since 2009-11-25

Therapeutic Equivalence (TE) Code AB

score 19 · Accepted Answer

Novo Nordisk, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTRADIOL, with a corresponding application number 20908.

Regulatory Information DISCN

With a dosage strength 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; VAGINAL

Reference Listed Drug Yes

Approved since 1999-03-26