Orange Book product

METFORMIN HYDROCHLORIDE 1GM

Orange Book ANDA 077880 · AMNEAL PHARMACEUTICALS NY LLC · Discontinued

Key facts

Proprietary name METFORMIN HYDROCHLORIDE
Active ingredients METFORMIN HYDROCHLORIDE
Strength 1GM
Dosage form TABLET
Route ORAL
Application ANDA077880
Applicant holder AMNEAL PHARMACEUTICALS NY LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 5, 2006

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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