Details for New Drug Application (NDA): 216602
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NDA 216602 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 216602
| Tradename: | FOSCARNET SODIUM |
| Applicant: | Amneal |
| Ingredient: | foscarnet sodium |
| Patents: | 0 |
Pharmacology for NDA: 216602
| Mechanism of Action | Chelating Activity DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 216602
Suppliers and Packaging for NDA: 216602
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSCARNET SODIUM | foscarnet sodium | INJECTABLE;INJECTION | 216602 | ANDA | Amneal Pharmaceuticals LLC | 70121-1744 | 70121-1744-2 | 12 POUCH in 1 CARTON (70121-1744-2) / 1 BAG in 1 POUCH / 250 mL in 1 BAG |
| FOSCARNET SODIUM | foscarnet sodium | INJECTABLE;INJECTION | 216602 | ANDA | Amneal Pharmaceuticals LLC | 70121-1744 | 70121-1744-7 | 10 POUCH in 1 CARTON (70121-1744-7) / 1 BAG in 1 POUCH / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.4GM/100ML | ||||
| Approval Date: | Mar 1, 2024 | TE: | AP | RLD: | No | ||||
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