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Generated: November 20, 2018

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Details for New Drug Application (NDA): 209080

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NDA 209080 describes TIGLUTIK KIT, which is a drug marketed by Italfarmaco Spa and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TIGLUTIK KIT profile page.

The generic ingredient in TIGLUTIK KIT is riluzole. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 209080
Tradename:TIGLUTIK KIT
Applicant:Italfarmaco Spa
Ingredient:riluzole
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 209080
Ingredient-typeBenzothiazoles
Medical Subject Heading (MeSH) Categories for 209080
Suppliers and Packaging for NDA: 209080
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIGLUTIK KIT riluzole SUSPENSION;ORAL 209080 NDA Itf Pharma, Inc. 70726-0303 70726-0303-2 2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-2) > 300 mL in 1 BOTTLE, PLASTIC (70726-0303-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/10ML
Approval Date:Sep 5, 2018TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 12, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF TREATING AMYOTROPHIC LATERAL SCLEROSIS IN A PATIENT IN NEED OF SUCH TREATMENT, SAID METHOD COMPRISING ADMINISTERING TO SAID PATIENT AN EFFECTIVE AMOUNT OF A SUSPENSION ACCORDING TO CLAIM 1

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