Orange Book product

CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML

Orange Book ANDA 074863 · WOCKHARDT BIO AG · Discontinued

Key facts

Proprietary name CLEMASTINE FUMARATE
Active ingredients CLEMASTINE FUMARATE
Strength EQ 0.5MG BASE/5ML
Dosage form SYRUP
Route ORAL
Application ANDA074863
Applicant holder WOCKHARDT BIO AG
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 13, 1998

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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