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CARDIZEM

NDA

DILTIAZEM HYDROCHLORIDE | N020027 | BIOVAIL LABORATORIES INTERNATIONAL SRL

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs11 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

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
Dec 30, 2004	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 24, 1991

No patent or exclusivity listings for this strength.

#003 — 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 18, 1995