Orange Book product

CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML **Federal Register determination that product was…

Orange Book ANDA 086833 · ACTAVIS MID ATLANTIC LLC · Discontinued

Key facts

Proprietary name CYPROHEPTADINE HYDROCHLORIDE
Active ingredients CYPROHEPTADINE HYDROCHLORIDE
Strength 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form SYRUP
Route ORAL
Application ANDA086833
Applicant holder ACTAVIS MID ATLANTIC LLC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 1, 1982

At a glance

  • None Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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