Details for New Drug Application (NDA): 213001
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NDA 213001 describes FOSCARNET SODIUM, which is a drug marketed by Amneal, Avet Lifesciences, Beijing, Fresenius Kabi Usa, Gland Pharma Ltd, and Hospira, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the FOSCARNET SODIUM profile page.
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.
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 213001
| Tradename: | FOSCARNET SODIUM |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | foscarnet sodium |
| Patents: | 0 |
Pharmacology for NDA: 213001
| Mechanism of Action | Chelating Activity DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 213001
Suppliers and Packaging for NDA: 213001
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSCARNET SODIUM | foscarnet sodium | INJECTABLE;INJECTION | 213001 | ANDA | Sagent Pharmaceuticals | 25021-189 | 25021-189-84 | 10 BAG in 1 CARTON (25021-189-84) / 250 mL in 1 BAG |
| FOSCARNET SODIUM | foscarnet sodium | INJECTABLE;INJECTION | 213001 | ANDA | Baxter Healthcare Corporation | 43066-089 | 43066-089-10 | 10 BAG in 1 CARTON (43066-089-10) / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.4GM/100ML | ||||
| Approval Date: | Apr 21, 2021 | TE: | AP | RLD: | No | ||||
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