Details for New Drug Application (NDA): 212483
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The generic ingredient in FOSCARNET SODIUM is foscarnet sodium. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the foscarnet sodium profile page.
Summary for 212483
Tradename: | FOSCARNET SODIUM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | foscarnet sodium |
Patents: | 0 |
Pharmacology for NDA: 212483
Mechanism of Action | Chelating Activity DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212483
Suppliers and Packaging for NDA: 212483
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FOSCARNET SODIUM | foscarnet sodium | INJECTABLE;INJECTION | 212483 | ANDA | Fresenius Kabi USA, LLC | 63323-875 | 63323-875-50 | 1 BOTTLE in 1 CARTON (63323-875-50) / 250 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.4GM/100ML | ||||
Approval Date: | Jan 29, 2021 | TE: | AP | RLD: | No |
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