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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 020068

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NDA 020068 describes FOSCAVIR, which is a drug marketed by Clinigen Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the FOSCAVIR profile page.

The generic ingredient in FOSCAVIR 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 020068

Tradename:	FOSCAVIR
Applicant:	Clinigen Hlthcare
Ingredient:	foscarnet sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020068

Mechanism of Action	Chelating Activity DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 020068

Antiviral Agents
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 020068

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068	NDA	Clinigen Limited	76310-024	76310-024-01	10 CARTON in 1 CARTON (76310-024-01) / 1 BOTTLE in 1 CARTON (76310-024-11) / 250 mL in 1 BOTTLE
FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068	NDA	Clinigen Limited	76310-024	76310-024-25	10 CARTON in 1 CARTON (76310-024-25) / 1 BOTTLE in 1 CARTON (76310-024-15) / 250 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2.4GM/100ML
Approval Date:	Sep 27, 1991	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020068

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	⤷ Try a Trial	⤷ Try a Trial
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	⤷ Try a Trial	⤷ Try a Trial
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	⤷ Try a Trial	⤷ Try a Trial
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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