Orange Book product

SEVELAMER CARBONATE 800MG

Orange Book ANDA 090975 · IMPAX LABORATORIES INC · Discontinued

Key facts

Proprietary name SEVELAMER CARBONATE
Active ingredients SEVELAMER CARBONATE
Strength 800MG
Dosage form TABLET
Route ORAL
Application ANDA090975
Applicant holder IMPAX LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 23, 2017

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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