Details for New Drug Application (NDA): 210864
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NDA 210864 describes SESQUIENT, which is a drug marketed by Lupin and is included in one NDA. There are five patents protecting this drug. Additional details are available on the SESQUIENT profile page.
The generic ingredient in SESQUIENT is fosphenytoin sodium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
The generic ingredient in SESQUIENT is fosphenytoin sodium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
Summary for 210864
| Tradename: | SESQUIENT |
| Applicant: | Lupin |
| Ingredient: | fosphenytoin sodium |
| Patents: | 5 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML) | ||||
| Approval Date: | Nov 5, 2020 | TE: | RLD: | Yes | |||||
| Patent: | 7,635,773 | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,410,077 | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,200,088 | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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