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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020075

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NDA 020075 describes LIORESAL, which is a drug marketed by Novartis and Saol Theraps Res Ltd and is included in two NDAs. It is available from two suppliers. Additional details are available on the LIORESAL profile page.

The generic ingredient in LIORESAL is baclofen. There are eighteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for NDA: 020075

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020075

Suppliers and Packaging for NDA: 020075

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIORESAL
baclofen
INJECTABLE;INTRATHECAL 020075 NDA Medtronic Neuromodulation 58281-560 58281-560-01 1 AMPULE in 1 PACKAGE, COMBINATION (58281-560-01) > 20 mL in 1 AMPULE
LIORESAL
baclofen
INJECTABLE;INTRATHECAL 020075 NDA Medtronic Neuromodulation 58281-560 58281-560-02 2 AMPULE in 1 PACKAGE, COMBINATION (58281-560-02) > 20 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength0.5MG/ML
Approval Date:Jun 17, 1992TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength2MG/ML
Approval Date:Jun 17, 1992TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength0.05MG/ML
Approval Date:Nov 7, 1996TE:APRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Medtronic
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Fish and Richardson
US Department of Justice
Queensland Health
Covington
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UBS

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