Drug application

CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE)

Drugs@FDA ANDA 074664 · PAI HOLDINGS PHARM

Key facts

Drug name CIMETIDINE HYDROCHLORIDE
Active ingredients CIMETIDINE HYDROCHLORIDE
Application type ANDA
Application number 074664
Company PAI HOLDINGS PHARM
Dosage forms SOLUTION, ORAL
Strength EQ 300MG BASE/5ML
Marketing status Prescription
TE codes AA
Reference listed drug No
Latest submission status date Oct 28, 1997

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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 · Source date:

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