Orange Book product

PENTOXIL 400MG

Orange Book ANDA 074962 · UPSHER SMITH LABORATORIES LLC · Discontinued

Key facts

Proprietary name PENTOXIL
Active ingredients PENTOXIFYLLINE
Strength 400MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA074962
Applicant holder UPSHER SMITH LABORATORIES LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 31, 1999

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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