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ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

NDA

ONDANSETRON HYDROCHLORIDE | N020403 | GLAXOSMITHKLINE

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Ben Venue Laboratories, Inc. - Citizen Petition FDA-2012-P-1068 · 3 docket documents Ben Venue Laboratories, Inc. filed this ANDA suitability petition on October 12, 2012 requesting a determination that a new strength of Ondansetron in 5% Dextrose Injection, 16 mg/25 mL (0.64 mg/mL) in single dose plastic containers, is suitable for submission as an ANDA, with expedited review reque	Other	2012-11-15	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

261 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 203 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cisplatin Disposition and Kidney Injury NCT03817970	Phase 3	Active	University of Colorado, Denver	72	2019-11-15 → 2027-12-31
Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia NCT03865290	Phase 2	Recruiting	Mayo Clinic	150	2019-04-02 → 2028-03
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron NCT04150614	Phase 4	Recruiting	University of Illinois at Chicago	90	2020-05-14 → 2026-07
Midazolam Versus Dexamethasone-ondansetron in Preventing Postoperative Nausea-vomiting for Laparoscopic Surgeries NCT03603119	N/A	Completed	Institute of Liver and Biliary Sciences, India	120	2018-05-01 → 2019-11-15
An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers NCT02648490	Phase 1	Completed	Henlix, Inc	19	2016-09 → 2019-06-28
Drug Interactions Between Paracetamol and Setrons in Pain Management NCT01432977	Phase 3	Completed	University Hospital, Limoges	72	2011-09 → 2012-06
Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)NCT00080444	Phase 3	Completed	Merck Sharp & Dohme LLC	50	2004-04 → 2007-03
Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron NCT01952626	N/A	Completed	Kyungpook National University Hospital	80	2013-04 → 2014-06
Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer NCT02441894	Phase 4	Completed	Sanofi	21	2015-04 → 2016-11
Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial NCT02456662	N/A	Completed	University of Rochester	319	2015-10-07 → 2019-04-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain14 active DMFs2 inactive

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

DR REDDYS LABORATORIES LTDONDANSETRON HYDROCHLORIDE DIHYDRATE USP

DMF 154362001

SCINOPHARM TAIWAN LTDONDANSETRON HYDROCHLORIDE USP

DMF 159902002

INKE SAONDANSETRON HYDROCHLORIDE

DMF 163172002

SUN PHARMACEUTICAL INDUSTRIES LTDONDANSETRON HYDROCHLORIDE USP

DMF 165622003

HIKAL LTDONDANSETRON HYDROCHLORIDE USP

DMF 167102003

CADILA PHARMACEUTICALS LTDONDANSETRON HYDROCHLORIDE USP

DMF 167862003

TARO PHARMACEUTICAL INDUSTRIES LTDONDANSETRON HYDROCHLORIDE USP

DMF 169762003

QILU PHARMACEUTICAL CO LTDONDANSETRON HYDROCHLORIDE (NON-STERILE API)

DMF 170342003

NATCO PHARMA LTDONDANSETRON HYDROCHLORIDE

DMF 181802005

APITORIA PHARMA PRIVATE LTDONDANSETRON HYDROCHLORIDE USP

DMF 190712005

NATCO PHARMA LTDONDANSETRON HYDROCHLORIDE (INJECTABLE GRADE)

DMF 206752007

IPCA LABORATORIES LTDONDANSETRON HYDROCHLORIDE USP

DMF 207712007

HIKMA PHARMACEUTICALSONDANSETRON HYDROCHLORIDE, USP

DMF 221812008

SMS PHARMACEUTICALS LTDONDANSETRON HYDROCHLORIDE USP

DMF 223402008

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveONDANSETRON HYDROCHLORIDE DIHYDRATE

DMF 170532003

NINGBO TEAM PHARMACEUTICAL CO LTDInactiveONDANSETRON HYDROCHLORIDE BULK FORM

DMF 233302009

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Sep 16, 2011	SUPPL -20	View Letter (PDF)
Jul 13, 2011	SUPPL -19	View Letter (PDF)
Sep 28, 2010	SUPPL -18	View Letter (PDF)
Sep 18, 2006	SUPPL -16	View Letter (PDF)
Jan 6, 2006	SUPPL -14	View Letter (PDF)
Dec 2, 2004	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 31, 1995

No patent or exclusivity listings for this strength.