U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 215003
Company: NOVITIUM PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML SUSPENSION;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/03/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215003Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2024 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
01/31/2023 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

PAROXETINE HYDROCHLORIDE

SUSPENSION;ORAL; EQ 10MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML SUSPENSION;ORAL Prescription No AB 215003 NOVITIUM PHARMA
PAXIL PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML SUSPENSION;ORAL Prescription Yes AB 020710 APOTEX
Back to Top