Orange Book product

BROMANYL 12.5MG/5ML;10MG/5ML

Orange Book ANDA 088343 · ALPHARMA US PHARMACEUTICALS DIVISION · Discontinued

Key facts

Proprietary name BROMANYL
Active ingredients BROMODIPHENHYDRAMINE HYDROCHLORIDE, CODEINE PHOSPHATE
Strength 12.5MG/5ML;10MG/5ML
Dosage form SYRUP
Route ORAL
Application ANDA088343
Applicant holder ALPHARMA US PHARMACEUTICALS DIVISION
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 15, 1984

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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