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Details for New Drug Application (NDA): 018264

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NDA 018264 describes DANTRIUM, which is a drug marketed by Par Sterile Products and is included in two NDAs. It is available from three suppliers. 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 NDA: 018264

Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018264

Suppliers and Packaging for NDA: 018264

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dantrolene sodium
INJECTABLE;INJECTION 018264 NDA Par Pharmaceutical, Inc. 42023-123 42023-123-06 6 VIAL in 1 CARTON (42023-123-06) > 60 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Expired Orange Book Patents for NDA: 018264

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Sterile Products
dantrolene sodium
INJECTABLE;INJECTION018264-001Approved Prior to Jan 1, 19823,415,821► Subscribe
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