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Details for New Drug Application (NDA): 076856

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NDA 076856 describes DANTROLENE SODIUM, which is a drug marketed by Mylan Institutional, Impax Labs, and Elite Labs Inc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the DANTROLENE SODIUM profile page.

The generic ingredient in DANTROLENE SODIUM 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: 076856

Tradename:
DANTROLENE SODIUM
Applicant:
Impax Labs
Ingredient:
dantrolene sodium
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076856

Suppliers and Packaging for NDA: 076856

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DANTROLENE SODIUM
dantrolene sodium
CAPSULE;ORAL 076856 ANDA Impax Generics 0115-4411 0115-4411-01 100 CAPSULE in 1 BOTTLE (0115-4411-01)
DANTROLENE SODIUM
dantrolene sodium
CAPSULE;ORAL 076856 ANDA Impax Generics 0115-4411 0115-4411-02 500 CAPSULE in 1 BOTTLE (0115-4411-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Mar 1, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Mar 1, 2005TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 1, 2005TE:ABRLD:No


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