Orange Book product

SILPHEN 12.5MG/5ML

Orange Book ANDA 072646 · LANNETT CO INC · Discontinued

Key facts

Proprietary name SILPHEN
Active ingredients DIPHENHYDRAMINE HYDROCHLORIDE
Strength 12.5MG/5ML
Dosage form SYRUP
Route ORAL
Application ANDA072646
Applicant holder LANNETT CO INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 27, 1992

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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