Drug application

PROMETHAZINE VC PLAIN (PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 088897 · XTTRIUM LABS INC

Key facts

Drug name PROMETHAZINE VC PLAIN
Active ingredients PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
Application type ANDA
Application number 088897
Company XTTRIUM LABS INC
Dosage forms SYRUP, ORAL
Strength 5MG/5ML;6.25MG/5ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jan 4, 1985

At a glance

  • 1–9 Submissions
  • 10–99 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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