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Serving leading biopharmaceutical companies globally:

Cipla
Colorcon
US Department of Justice
UBS
Boehringer Ingelheim
Express Scripts
Harvard Business School
Argus Health
Covington
Medtronic

Generated: January 23, 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 42023-124-01 100 CAPSULE in 1 BOTTLE (42023-124-01)
DANTRIUM dantrolene sodium CAPSULE;ORAL 017443 NDA Par Pharmaceutical, Inc. 42023-125 42023-125-01 100 CAPSULE in 1 BOTTLE (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 017443-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-002 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-003 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
US Department of Justice
AstraZeneca
Julphar
Express Scripts
QuintilesIMS
Deloitte
Accenture
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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