Details for New Drug Application (NDA): 209080
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NDA 209080 describes TIGLUTIK KIT, which is a drug marketed by Italfarmaco Sa 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. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.
The generic ingredient in TIGLUTIK KIT is riluzole. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 209080
| Tradename: | TIGLUTIK KIT |
| Applicant: | Italfarmaco Sa |
| Ingredient: | riluzole |
| Patents: | 1 |
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 | EDW PHARMA, INC | 70726-0303 | 70726-0303-1 | 2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-1) / 300 mL in 1 BOTTLE, PLASTIC (70726-0303-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 50MG/10ML | ||||
| Approval Date: | Sep 5, 2018 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,765,150 | Patent Expiration: | Mar 12, 2029 | Product Flag? | Y | Substance 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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