Orange Book product

CYPROHEPTADINE HYDROCHLORIDE 4MG

Orange Book ANDA 040537 · MOUNTAIN LLC · Prescription

Key facts

Proprietary name CYPROHEPTADINE HYDROCHLORIDE
Active ingredients CYPROHEPTADINE HYDROCHLORIDE
Strength 4MG
Dosage form TABLET
Route ORAL
Application ANDA040537
Applicant holder MOUNTAIN LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 30, 2003

At a glance

  • 10–99 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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