Orange Book product

TOLTERODINE TARTRATE 2MG

Orange Book ANDA 204397 · HETERO LABS LTD UNIT V · Prescription

Key facts

Proprietary name TOLTERODINE TARTRATE
Active ingredients TOLTERODINE TARTRATE
Strength 2MG
Dosage form TABLET
Route ORAL
Application ANDA204397
Applicant holder HETERO LABS LTD UNIT V
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 2, 2021

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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