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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Cantor Fitzgerald
Colorcon
Julphar
Federal Trade Commission
Farmers Insurance
Express Scripts
US Army
Cerilliant

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017443

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NDA 017443 describes DANTRIUM, which is a drug marketed by Par Sterile Products and is included in two NDAs. It is available from one supplier. Additional details are available on the DANTRIUM profile page.

The generic ingredient in DANTRIUM is dantrolene sodium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.
Summary for 017443
Tradename:DANTRIUM
Applicant:Par Sterile Products
Ingredient:dantrolene sodium
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 017443
Medical Subject Heading (MeSH) Categories for 017443
Suppliers and Packaging for NDA: 017443
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DANTRIUM dantrolene sodium CAPSULE;ORAL 017443 NDA Par Pharmaceutical, Inc. 42023-124 N 42023-124-01
DANTRIUM dantrolene sodium CAPSULE;ORAL 017443 NDA Par Pharmaceutical, Inc. 42023-125 N 42023-125-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 017443

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-003 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Healthtrust
Colorcon
AstraZeneca
Fish and Richardson
Fuji
McKesson
Covington
UBS

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