Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202074
Company: TEVA PHARMS

Products on ANDA 202074

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202074

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2021	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/26/2021	SUPPL-4	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
12/19/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/19/2014	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/19/2014	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202074

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 25MG BASE;EQ 3MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE;ORAL	Prescription	No	AB	078901	EPIC PHARMA LLC
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE;ORAL	Prescription	No	AB	077742	PAR PHARM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE;ORAL	Prescription	No	AB	202074	TEVA PHARMS
SYMBYAX	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	021520	LILLY