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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202133
Company: TWI PHARMS

Medication Guide

Summary Review

Products on NDA 202133

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202133

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
08/18/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202133s009s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202133Orig1s009,s016ltr.pdf
09/20/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202133s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202133Orig1s012ltr.pdf
08/18/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202133s009s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202133Orig1s009,s016ltr.pdf
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

Labels for NDA 202133

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202133s009s016lbl.pdf
08/18/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202133s009s016lbl.pdf
09/20/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202133s012lbl.pdf
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

Therapeutic Equivalents for NDA 202133

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	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	209419	ENDO OPERATIONS
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	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	Yes	AB	202133	TWI PHARMS

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