Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075292
Company: NOSTRUM LABS INC

• Other Important Information from FDA

Products on ANDA 075292

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 075292

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2002	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75292ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75292TA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/20/2021	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
09/12/2021	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/04/2017	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
09/02/2014	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
05/29/2012	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
12/02/2008	SUPPL-15	Labeling		Label is not available on this site.
06/29/2007	SUPPL-12	Labeling		Label is not available on this site.
06/29/2007	SUPPL-11	Labeling		Label is not available on this site.
08/29/2006	SUPPL-10	Labeling		Label is not available on this site.
08/29/2006	SUPPL-9	Labeling		Label is not available on this site.
03/15/2006	SUPPL-7	Labeling		Label is not available on this site.
05/17/2005	SUPPL-5	Labeling		Label is not available on this site.
05/17/2005	SUPPL-4	Labeling		Label is not available on this site.
09/03/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075292

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