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Details for New Drug Application (NDA): 078378

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NDA 078378 describes REVONTO, which is a drug marketed by Us Worldmeds and is included in one NDA. It is available from one supplier. Additional details are available on the REVONTO profile page.

The generic ingredient in REVONTO 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: 078378

Tradename:
REVONTO
Applicant:
Us Worldmeds
Ingredient:
dantrolene sodium
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078378

Suppliers and Packaging for NDA: 078378

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVONTO
dantrolene sodium
INJECTABLE;INJECTION 078378 ANDA US WorldMeds, LLC 27505-003 27505-003-68 6 VIAL, GLASS in 1 CARTON (27505-003-68) > 60 mL in 1 VIAL, GLASS
REVONTO
dantrolene sodium
INJECTABLE;INJECTION 078378 ANDA US WorldMeds, LLC 27505-003 27505-003-67 6 VIAL, GLASS in 1 CARTON (27505-003-67) > 60 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Jul 24, 2007TE:APRLD:No


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