Orange Book product

FLUVOXAMINE MALEATE 100MG

Orange Book ANDA 075897 · ANI PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name FLUVOXAMINE MALEATE
Active ingredients FLUVOXAMINE MALEATE
Strength 100MG
Dosage form TABLET
Route ORAL
Application ANDA075897
Applicant holder ANI PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 25, 2001

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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