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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206937
Company: TORRENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription None No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/21/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2021 SUPPL-6 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/02/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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