Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209419
Company: PAR PHARM INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;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
11/16/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209419Orig1s000ltr.pdf

FLUOXETINE HYDROCHLORIDE

TABLET;ORAL; EQ 60MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription Yes AB 202133 ALMATICA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 213265 AUROBINDO PHARMA LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 211721 DR REDDYS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 209695 INVENTIA HLTHCARE
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 211632 LUPIN LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 209419 PAR PHARM INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 211282 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 211477 TARO
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 211051 TEVA PHARMS USA

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