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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077849
Company: LANNETT CO INC

Products on ANDA 077849

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 077849

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/2007	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
08/18/2023	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2021	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/07/2021	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/07/2021	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/04/2017	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/27/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/18/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/16/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/11/2009	SUPPL-4	Labeling		Label is not available on this site.
03/11/2009	SUPPL-3	Labeling		Label is not available on this site.
05/29/2008	SUPPL-2	Labeling		Label is not available on this site.
10/10/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077849

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

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