Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200151
Company: TEVA PHARMS USA

Products on ANDA 200151

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SELFEMRA	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No
SELFEMRA	FLUOXETINE HYDROCHLORIDE	EQ 15MG BASE	TABLET;ORAL	Discontinued	None	No	No
SELFEMRA	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/2014	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-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/09/2023	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/20/2020	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/04/2017	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/21/2016	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/18/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.