Orange Book product

DISOBROM 6MG;120MG

Orange Book ANDA 070770 · SANDOZ INC · Discontinued

Key facts

Proprietary name DISOBROM
Active ingredients DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE SULFATE
Strength 6MG;120MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA070770
Applicant holder SANDOZ INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 30, 1991

At a glance

  • None 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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