Orange Book product

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG

Orange Book ANDA 077705 · MYLAN PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Active ingredients FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDE
Strength 10MG;12.5MG
Dosage form TABLET
Route ORAL
Application ANDA077705
Applicant holder MYLAN PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 14, 2006

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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