Drug application

PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 040449 · ABLE

Key facts

Drug name PROMETHAZINE HYDROCHLORIDE
Active ingredients PROMETHAZINE HYDROCHLORIDE
Application type ANDA
Application number 040449
Company ABLE
Dosage forms SUPPOSITORY, RECTAL
Strength 50MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Feb 27, 2003

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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