Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201588
Company: SANDOZ INC

Products on ANDA 201588

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 201588

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2011	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201588s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/29/2024	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/29/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/29/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/29/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201588

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