Orange Book product

METFORMIN HYDROCHLORIDE 750MG

Orange Book ANDA 211052 · YICHANG HUMANWELL PHARMACEUTICAL CO LTD · Prescription

Key facts

Proprietary name METFORMIN HYDROCHLORIDE
Active ingredients METFORMIN HYDROCHLORIDE
Strength 750MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA211052
Applicant holder YICHANG HUMANWELL PHARMACEUTICAL CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 24, 2018

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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