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DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

NDA

DILTIAZEM HYDROCHLORIDE | N215252 | EXELA PHARMA SCIENCES LLC

2 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Fresenius Kabi USA, LLC FDA-2024-P-1131 · 5 docket documents Fresenius Kabi USA, LLC submitted this citizen petition on March 5, 2024, requesting that the FDA Commissioner determine whether Exela Pharma Sciences LLC withdrew Diltiazem Hydrochloride in Dextrose Injection 125 mg/125 mL and 250 mg/250 mL (NDA 215252) for reasons of safety or efficacy, as the pro	505(q)	2024-03-06	Granted	Fresenius Kabi USA, LLC

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

Clinical Trials

70 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts NCT04310995	Phase 4	Active	Ruijin Hospital	150	2020-06-02 → 2026-05
Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure NCT04153032	Phase 2	Recruiting	American University of Beirut Medical Center	183	2019-12-01 → 2026-01-30
Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem NCT00319982	Phase 2/3	Completed	Brigham and Women's Hospital	39	2006-01 → 2013-12
Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin NCT01422382	Phase 4	Completed	Kowa Research Institute, Inc.	28	2011-05 → 2011-07
A Study of LY2623091 in Healthy Participants NCT02300259	Phase 1	Completed	Eli Lilly and Company	48	2014-11 → 2015-04
Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction NCT00712894	Phase 4	Completed	Fudan University	102	2006-12 → 2009-08
Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial NCT03472495	Phase 4	Completed	Virginia Commonwealth University	19	2018-06-01 → 2021-03-21
Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects NCT02080780	Phase 1	Completed	Ventrus Biosciences, Inc	24	2013-09 → 2013-10
A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers NCT02319148	Phase 1	Completed	Pfizer	22	2014-07 → 2014-10
Effect of Diltiazem on Coronary Artery Ectasia NCT02024919	N/A	Completed	Ankara University	60	2012-06 → 2015-05

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

API Supply Chain7 active DMFs12 inactive

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

LUSOCHIMICA SPADILTIAZEM HYDROCHLORIDE

DMF 66861986

TAPI NL BVDILTIAZEM HYDROCHLORIDE USP

DMF 72391987

FIS FABBRICA ITALIANA SINTETICI SPADILTIAZEM HYDROCHLORIDE

DMF 76001988

PIRAMAL PHARMA LTDDILTIAZEM HYDROCHLORIDE USP

DMF 147132000

DIVIS LABORATORIES LTDDILTIAZEM HYDROCHLORIDE USP

DMF 152672001

CHEMECA DRUGS PRIVATE LTDDILTIAZEM HYDROCHLORIDE USP

DMF 342202020

VASUDHA PHARMA CHEM LTDDILTIAZEM HYDROCHLORIDE USP

DMF 407222024

TORCAN CHEMICAL LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 72401987

PCASInactiveDILTIAZEM HYDROCHLORIDE

DMF 77561988

FABBRICA ITALIANA SINTETICI SPAInactiveDILTIAZEM HYDROCHLORIDE

DMF 79081989

HAMARI CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 85481990

ICHIKAWA LAB CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 87061990

TATEISHI SEIYAKU CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 87991990

MITSUBISHI TANABE PHARMA CORPInactiveDILTIAZEM HYDROCHLORIDE (PROCESS C)

DMF 103811993

SUMITRA PHARMACEUTICALS AND CHEMICALS LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 104661993

DR REDDYS LABORATORIES LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 115041995

NATCO PHARMA LTDInactiveDILTIAZEM HYDROCHLORIDE, USP

DMF 131301998

SYN-TECH CHEM AND PHARM CO LTDInactiveDILTIAZEM HYDROCHLORIDE USP

DMF 146592000

FARMAK ASInactiveDILTIAZEM HYDROCHLORIDE

DMF 154182001

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 29, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 28, 2021

No patent or exclusivity listings for this strength.

#002 — 250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Oct 28, 2021