Orange Book product

DILTIAZEM HYDROCHLORIDE 120MG

Orange Book ANDA 075116 · VALEANT PHARMACEUTICALS NORTH AMERICA LLC · Prescription

Key facts

Proprietary name DILTIAZEM HYDROCHLORIDE
Active ingredients DILTIAZEM HYDROCHLORIDE
Strength 120MG
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Application ANDA075116
Applicant holder VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB3
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 23, 1999

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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