Orange Book product

SEVELAMER CARBONATE 800MG/PACKET

Orange Book ANDA 210464 · DR REDDYS LABORATORIES LTD · Prescription

Key facts

Proprietary name SEVELAMER CARBONATE
Active ingredients SEVELAMER CARBONATE
Strength 800MG/PACKET
Dosage form FOR SUSPENSION
Route ORAL
Application ANDA210464
Applicant holder DR REDDYS LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 25, 2018

At a glance

  • 1–9 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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