Orange Book product

OMEPRAZOLE 10MG

Orange Book ANDA 075876 · STRIDES PHARMA GLOBAL PTE LTD · Discontinued

Key facts

Proprietary name OMEPRAZOLE
Active ingredients OMEPRAZOLE
Strength 10MG
Dosage form CAPSULE, DELAYED REL PELLETS
Route ORAL
Application ANDA075876
Applicant holder STRIDES PHARMA GLOBAL PTE LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 29, 2003

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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