Approved Drug Products containing 13217 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 13217

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is METAXALONE, with a corresponding application number 13217.

Regulatory Information DISCN

With a dosage strength 800MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2002-08-30

score 19 · Accepted Answer

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is METAXALONE, with a corresponding application number 13217.

Regulatory Information DISCN

With a dosage strength 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01