Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202133
Company: ALVOGEN
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 Yes 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
10/06/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202133s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202133s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202133_fluoxetine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202133Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202133Orig1s004,s005ltr.pdf
01/04/2017 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202133Orig1s004,s005ltr.pdf
07/18/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202133s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202133Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf
01/04/2017 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf
01/04/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf
07/18/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202133s003lbl.pdf
10/06/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202133s000lbl.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 ALVOGEN
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 211477 APPCO PHARMA LLC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 211721 DR REDDYS LABS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 212191 G AND W LABS INC
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 211051 TEVA PHARMS USA

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