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Last Updated: June 21, 2024

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.
Summary for 216602
Tradename:FOSCARNET SODIUM
Applicant:Amneal
Ingredient:foscarnet sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 216602
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:RXDosage:INJECTABLE;INJECTIONStrength2.4GM/100ML
Approval Date:Mar 1, 2024TE:APRLD:No

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