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ZYPREXA

NDA

OLANZAPINE | N021253 | CHEPLAPHARM REGISTRATION GMBH

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain26 active DMFs12 inactive

21 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDOLANZAPINE (FORM 1) USP

DMF 152992001

SOLARA ACTIVE PHARMA SCIENCES LTDOLANZAPINE USP

DMF 182602005

NEULAND LABORATORIES LTDOLANZAPINE FORM-1 USP

DMF 192822006

TAPI NL BVOLANZAPINE USP

DMF 202182007

HETERO DRUGS LTDOLANZAPINE (FORM-1)

DMF 205912007

JUBILANT PHARMOVA LTDOLANZAPINE USP (FORM-I)

DMF 209902007

SUN PHARMACEUTICAL INDUSTRIES LTDOLANZAPINE USP

DMF 215062008

APOTEX INCOLANZAPINE USP

DMF 219802008

CADILA PHARMACEUTICALS LTDOLANZAPINE FORM-I USP

DMF 223012008

TORRENT PHARMACEUTICALS LTDOLANZAPINE

DMF 225552009

APITORIA PHARMA PRIVATE LTDOLANZAPINE USP (NON-STERILE DRUG SUBSTANCE)

DMF 235252010

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDOLANZAPINE

DMF 235972010

ORBION PHARMACEUTICALS PRIVATE LTDOLANZAPINE

DMF 240202010

MACLEODS PHARMACEUTICALS LTDOLANZAPINE USP

DMF 243332010

QILU PHARMACEUTICAL CO LTDOLANZAPINE

DMF 251752011

ZYDUS LIFESCIENCES LTDOLANZAPINE USP

DMF 260722012

INKE SAOLANZAPINE

DMF 266942013

HEC PHARM CO LTDOLANZAPINE NON-STERILE BULK DRUG SUBSTANCE

DMF 267632012

APOTEX INCOLANZAPINE USP

DMF 294442015

APITORIA PHARMA PRIVATE LTDOLANZAPINE USP (CRYSTALLINE POLYMORPH FORM-II)

DMF 297892015

JUBILANT PHARMOVA LTDOLANZAPINE USP

DMF 303522016

CHROMO LABORATORIES INDIA PRIVATE LTDOLANZAPINE USP

DMF 332212022

IPCA LABORATORIES LTDOLANZAPINE USP

DMF 371012022

APOTEX INCOLANZAPINE FORM II USP

DMF 371222022

LEE PHARMA LTDOLANZAPINE (FORM-I)

DMF 391502023

TAPI NL BVOLANZAPINE FORM II

DMF 400352025

CIPLA LTDInactiveOLANZAPINE

DMF 150522000

VENKAT PHARMA LTDInactiveOLANZAPINE

DMF 181082005

MYLAN LABORATORIES LTDInactiveOLANZAPINE

DMF 188672005

CADILA HEALTHCARE LTDInactiveOLANZAPINE

DMF 191682006

LEK PHARMACEUTICALS DDInactiveOLANZAPINE

DMF 203542007

RANBAXY LABORATORIES LTDInactiveOLANZAPINE DRUG SUBSTANCE

DMF 219472008

ALKEM LABORATORIES LTDInactiveOLANZAPINE USP

DMF 240162010

JIANGSU HANSOH PHARMACEUTICAL CO LTDInactiveOLANZAPINE NON-STERILE BULK DRUG SUBSTANCE

DMF 244802010

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveOLANZAPINE USP

DMF 272192013

KYONGBO PHARMACEUTICAL CO LTDInactiveOLANZAPINE

DMF 289762015

CIPLA LTDInactiveOLANZAPINE USP

DMF 290632015

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDInactiveOLANZAPINE USP, NON-STERILE

DMF 300412016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

24 letters from Drugs@FDA

Date	Submission	Document
Feb 3, 2026	SUPPL -67	View Letter (PDF)
Feb 7, 2025	SUPPL -66	View Letter (PDF)
Apr 24, 2020	SUPPL -61	View Letter (PDF)
Apr 22, 2020	SUPPL -62	View Letter (PDF)
Oct 23, 2019	SUPPL -60	View Letter (PDF)
Mar 29, 2018	SUPPL -59	View Letter (PDF)
Mar 2, 2017	SUPPL -57	View Letter (PDF)
Mar 2, 2017	SUPPL -58	View Letter (PDF)
Oct 14, 2016	SUPPL -56	View Letter (PDF)
Dec 23, 2014	SUPPL -48	View Letter (PDF)
Dec 6, 2010	SUPPL -45	View Letter (PDF)
Jun 3, 2010	SUPPL -39	View Letter (PDF)
Jun 3, 2010	SUPPL -43	View Letter (PDF)
Feb 1, 2010	SUPPL -37	View Letter (PDF)
Nov 19, 2009	SUPPL -36	View Letter (PDF)
Aug 19, 2008	SUPPL -33	View Letter (PDF)
Jul 10, 2007	SUPPL -26	View Letter (PDF)
Dec 28, 2006	SUPPL -21	View Letter (PDF)
Sep 18, 2006	SUPPL -6	View Letter (PDF)
Mar 1, 2006	SUPPL -16	View Letter (PDF)
Feb 22, 2006	SUPPL -4	View Letter (PDF)
Feb 22, 2006	SUPPL -12	View Letter (PDF)
Sep 15, 2005	SUPPL -15	View Letter (PDF)
Apr 7, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/VIAL

RLDAP

0 patents0 exclusivities▴

POWDER;INTRAMUSCULAR | Approved: Mar 29, 2004

No patent or exclusivity listings for this strength.