Orange Book product

DILTIAZEM HYDROCHLORIDE 300MG

Orange Book ANDA 203023 · SUN PHARMACEUTICAL INDUSTRIES LTD · Discontinued

Key facts

Proprietary name DILTIAZEM HYDROCHLORIDE
Active ingredients DILTIAZEM HYDROCHLORIDE
Strength 300MG
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Application ANDA203023
Applicant holder SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 8, 2017

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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