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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217466
Company: ASPIRO

Products on ANDA 217466

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLANZAPINE	OLANZAPINE	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217466

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217466

OLANZAPINE

INJECTABLE;INTRAMUSCULAR; 10MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLANZAPINE	OLANZAPINE	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	No	AP	201741	AM REGENT
OLANZAPINE	OLANZAPINE	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	No	AP	217466	ASPIRO
OLANZAPINE	OLANZAPINE	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	No	AP	210968	EUGIA PHARMA
OLANZAPINE	OLANZAPINE	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	No	AP	201588	SANDOZ INC
ZYPREXA	OLANZAPINE	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	Yes	AP	021253	CHEPLAPHARM

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