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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 six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the foscarnet sodium profile page.

Summary for NDA: 020068

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

Pharmacology for NDA: 020068

Ingredient-typePyrophosphate Analog
Mechanism of ActionDNA Polymerase 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 Healthcare Ltd. 76310-024 76310-024-25 10 CARTON in 1 CARTON (76310-024-25) > 1 BOTTLE in 1 CARTON > 250 mL in 1 BOTTLE
FOSCAVIR
foscarnet sodium
INJECTABLE;INJECTION 020068 NDA Clinigen Healthcare Ltd. 76310-024 76310-024-01 10 CARTON in 1 CARTON (76310-024-01) > 1 BOTTLE in 1 CARTON > 250 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.4GM/100ML
Approval Date:Sep 27, 1991TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020068

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Clinigen Hlthcare
FOSCAVIR
foscarnet sodium
INJECTABLE;INJECTION020068-001Sep 27, 19914,215,113► subscribe
Clinigen Hlthcare
FOSCAVIR
foscarnet sodium
INJECTABLE;INJECTION020068-001Sep 27, 19914,771,041► subscribe
Clinigen Hlthcare
FOSCAVIR
foscarnet sodium
INJECTABLE;INJECTION020068-001Sep 27, 19914,665,062► subscribe
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