Drug application

PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 089109 · TEVA

Key facts

Drug name PROMETHAZINE HYDROCHLORIDE
Active ingredients PROMETHAZINE HYDROCHLORIDE
Application type ANDA
Application number 089109
Company TEVA
Dosage forms TABLET, ORAL
Strength 25MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Sep 10, 1985

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None 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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