Orange Book product

ZOLPIDEM TARTRATE 10MG

Orange Book ANDA 076062 · STRIDES PHARMA GLOBAL PTE LTD · Discontinued

Key facts

Proprietary name ZOLPIDEM TARTRATE
Active ingredients ZOLPIDEM TARTRATE
Strength 10MG
Dosage form TABLET
Route ORAL
Application ANDA076062
Applicant holder STRIDES PHARMA GLOBAL PTE LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 23, 2007

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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