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STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

NDA

STERILE WATER FOR INJECTION | N018233 | OTSUKA ICU MEDICAL LLC

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

9 trials from ClinicalTrials.gov — 5 recruiting, 1 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function NCT04398745	Phase 1	Active	GlaxoSmithKline	36	2020-10-09 → 2027-03-11
NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer NCT07677579	Phase 2	Not Yet Recruiting	Northwell Health	26	2026-08-30 → 2028-12-30
A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials NCT04064060	Phase 3	Recruiting	Celgene	665	2019-08-12 → 2028-05-12
Impact of Bupivacaine Dilution With Dextrose or Saline on Infraclavicular Block Outcomes NCT07386327	N/A	Recruiting	Burçin Alaçam, MD	90	2026-03-09 → 2026-07-15
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks NCT06361537	Phase 3	Recruiting	Octapharma	124	2024-04-30 → 2027-06
Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Followed by an Open-label Patient Cohort NCT06813339	Early Phase 1	Recruiting	Cyclarity Therapeutics, Inc.	84	2025-02-25 → 2027-12-30
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis NCT05160532	Phase 2	Completed	Mayo Clinic	48	2022-04-10 → 2025-05-31
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia NCT04085523	Phase 2	Completed	Ascendis Pharma A/S	57	2020-06-24 → 2024-10-01
A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer NCT06692959	Phase 2	Terminated	University of Southampton	3	2025-06-16 → 2026-06-11

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

API Supply Chain5 active DMFs9 inactive

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

SIMTRA US LLCSTERILE WATER FOR INJECTION FOR RECONSTITUTION

DMF 159252002

CSL BEHRING GMBHSTERILE WATER FOR INJECTION

DMF 192572006

ROVI PHARMA INDUSTRIAL SERVICES SASTERILE WATER FOR INJECTION USP 0.5 ML

DMF 239922010

ROVI PHARMA INDUSTRIAL SERVICES SASTERILE WATER FOR INJECTION 10 ML PREFILLED SYRINGE

DMF 267582012

ROVI PHARMA INDUSTRIAL SERVICES SASTERILE WATER FOR INJECTION 2.2ML PREFILLED SYRINGE

DMF 304192016

LABORATOIRES SERONO SAInactiveSTERILE WATER FOR INJECTION

DMF 104731993

GENSIA LABORATORIES LTDInactiveSTERILE WATER FOR INJECTION

DMF 106961994

VETTER PHARMA FERTIGUNG GMBH AND CO KGInactiveSTERILE WATER FOR INJECTION

DMF 116141995

SCHERING PLOUGH PRODUCTS INCInactiveSTERILE WATER FOR INJECTION

DMF 124431997

JENAHEXAL PHARMA GMBHInactiveSTERILE WATER FOR INJECTION

DMF 154682001

TEVA PARENTERAL MEDICINES INCInactiveSTERILE WATER FOR INJECTION USP

DMF 159622002

ITALFARMACO SPAInactiveSTERILE WATER FOR INJECTION USP

DMF 226852009

ROVI PHARMA INDUSTRIAL SERVICES SAInactiveSTERILE WATER FOR INJECTION USP 2.0 ML

DMF 239912010

OTSUKA AMERICA PHARMACEUTICAL INCInactiveSTERILE WATER FOR INJECTION USP, 2 ML VIAL

DMF 252402011

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 8, 2007	SUPPL -68	View Letter (PDF)
Jan 26, 2005	SUPPL -63	View Letter (PDF)
Jan 24, 2003	SUPPL -62	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100%

RLDAP

0 patents0 exclusivities▴

LIQUID;N/A | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.