Orange Book product

BENZPHETAMINE HYDROCHLORIDE 50MG

Orange Book ANDA 090968 · KVK TECH INC · Prescription

Key facts

Proprietary name BENZPHETAMINE HYDROCHLORIDE
Active ingredients BENZPHETAMINE HYDROCHLORIDE
Strength 50MG
Dosage form TABLET
Route ORAL
Application ANDA090968
Applicant holder KVK TECH INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jul 20, 2010

At a glance

  • 1–9 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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