Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075506
Company: TEVA

• Other Important Information from FDA

Products on ANDA 075506

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075506

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2001	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75506ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75506_Prozac.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
09/21/2021	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/30/2021	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/27/2016	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
07/17/2014	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/31/2012	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/31/2012	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/06/2010	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
07/09/2009	SUPPL-14	Labeling		Label is not available on this site.
10/22/2008	SUPPL-13	Labeling		Label is not available on this site.
02/14/2008	SUPPL-11	Labeling		Label is not available on this site.
02/14/2008	SUPPL-10	Labeling		Label is not available on this site.
03/28/2007	SUPPL-8	Labeling		Label is not available on this site.
08/17/2006	SUPPL-7	Labeling		Label is not available on this site.
01/31/2006	SUPPL-6	Labeling		Label is not available on this site.
01/31/2006	SUPPL-5	Labeling		Label is not available on this site.
09/13/2004	SUPPL-3	Labeling		Label is not available on this site.
11/24/2003	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075506

FLUOXETINE HYDROCHLORIDE

SOLUTION;ORAL; EQ 20MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	216953	APTAPHARMA INC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	079209	AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	077849	LANNETT CO INC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	075292	NOSTRUM LABS INC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	216448	NOVITIUM PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	076015	PHARM ASSOC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	075506	TEVA