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Details for New Drug Application (NDA): 019818

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NDA 019818 describes ADAGEN, which is a drug marketed by Sigma Tau and is included in one NDA. It is available from one supplier. Additional details are available on the ADAGEN profile page.

The generic ingredient in ADAGEN is pegademase bovine. One supplier is listed for this compound. Additional details are available on the pegademase bovine profile page.

Summary for NDA: 019818

Tradename:
ADAGEN
Applicant:
Sigma Tau
Ingredient:
pegademase bovine
Patents:0
Therapeutic Class:Enzyme Replacements/Modifiers

Pharmacology for NDA: 019818

Ingredient-typeAdenosine Deaminase

Suppliers and Packaging for NDA: 019818

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAGEN
pegademase bovine
INJECTABLE;INJECTION 019818 NDA Sigma-Tau Pharmaceuticals, Inc. 57665-001 57665-001-01 4 VIAL, SINGLE-USE in 1 BOX (57665-001-01) > 1.5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250 UNITS/ML
Approval Date:Mar 21, 1990TE:RLD:Yes

Expired Orange Book Patents for NDA: 019818

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sigma Tau
ADAGEN
pegademase bovine
INJECTABLE;INJECTION019818-001Mar 21, 19904,179,337► subscribe
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