Details for New Drug Application (NDA): 212640
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The generic ingredient in EXSERVAN is riluzole. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 212640
Tradename: | EXSERVAN |
Applicant: | Aquestive |
Ingredient: | riluzole |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212640
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EXSERVAN | riluzole | FILM;ORAL | 212640 | NDA | Mitsubishi Tanabe Pharma America, Inc. | 70510-2201 | 70510-2201-2 | 60 POUCH in 1 CARTON (70510-2201-2) / 1 FILM in 1 POUCH (70510-2201-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 22, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 3, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 20, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 212640
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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