Drug application

PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)

Drugs@FDA ANDA 212645 · CADILA PHARMS LTD

Key facts

Drug name PAROXETINE HYDROCHLORIDE
Active ingredients PAROXETINE HYDROCHLORIDE
Application type ANDA
Application number 212645
Company CADILA PHARMS LTD
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength EQ 12.5MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Aug 27, 2021

At a glance

  • 1–9 Submissions
  • 1–9 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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