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Details for New Drug Application (NDA): 009330

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NDA 009330 describes LANOXIN PEDIATRIC, which is a drug marketed by Covis Pharma Sarl and is included in one NDA. It is available from two suppliers. Additional details are available on the LANOXIN PEDIATRIC profile page.

The generic ingredient in LANOXIN PEDIATRIC is digoxin. There are ten drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for NDA: 009330

Tradename:
LANOXIN
Applicant:
Covis Pharma Sarl
Ingredient:
digoxin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 009330

Ingredient-typeCardiac Glycosides

Suppliers and Packaging for NDA: 009330

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANOXIN
digoxin
INJECTABLE;INJECTION 009330 NDA Covis Pharmaceuticals, Inc. 24987-260 24987-260-10 10 AMPULE in 1 BOX (24987-260-10) > 2 mL in 1 AMPULE
LANOXIN
digoxin
INJECTABLE;INJECTION 009330 NDA Covis Pharmaceuticals, Inc. 24987-262 24987-262-10 10 AMPULE in 1 BOX (24987-262-10) > 1 mL in 1 AMPULE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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