Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075514
Company: WOCKHARDT BIO AG

• Other Important Information from FDA

Products on ANDA 075514

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 075514

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2002	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
09/21/2021	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/30/2021	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/04/2017	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/27/2016	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/23/2014	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/06/2010	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2009	SUPPL-9	Labeling		Label is not available on this site.
06/03/2008	SUPPL-8	Labeling		Label is not available on this site.
06/03/2008	SUPPL-7	Labeling		Label is not available on this site.
10/10/2007	SUPPL-6	Labeling		Label is not available on this site.
05/09/2007	SUPPL-5	Labeling		Label is not available on this site.
03/02/2006	SUPPL-3	Labeling		Label is not available on this site.
08/31/2005	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075514

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	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	076015	PHARM ASSOC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	075506	TEVA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	075514	WOCKHARDT BIO AG