Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076015
Company: PHARM ASSOC

• Other Important Information from FDA

• Safety Labeling Change Order Letter

Products on ANDA 076015

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076015

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2002	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2021	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
08/27/2021	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
08/27/2021	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/27/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/11/2014	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/11/2014	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/31/2012	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/26/2013	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/20/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/28/2009	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/02/2009	SUPPL-4	Labeling		Label is not available on this site.
01/31/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076015

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