Drug application

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE, SPIRONOLACTONE)

Drugs@FDA ANDA 089534 · SUN PHARM INDUSTRIES

Key facts

Drug name SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Active ingredients HYDROCHLOROTHIAZIDE, SPIRONOLACTONE
Application type ANDA
Application number 089534
Company SUN PHARM INDUSTRIES
Dosage forms TABLET, ORAL
Strength 25MG;25MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 2, 1987

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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