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. Nine 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: | ⤷ Try a Trial | Patent Expiration: | Apr 3, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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