Orange Book product

MESALAMINE 4GM/60ML

Orange Book ANDA 076841 · G AND W LABORATORIES INC · Discontinued

Key facts

Proprietary name MESALAMINE
Active ingredients MESALAMINE
Strength 4GM/60ML
Dosage form ENEMA
Route RECTAL
Application ANDA076841
Applicant holder G AND W LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 30, 2004

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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