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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 009330

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LANOXIN (DIGOXIN)
0.25MG/ML
Marketing Status: Prescription
Active Ingredient: DIGOXIN
Proprietary Name: LANOXIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.25MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N009330
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
LANOXIN PEDIATRIC (DIGOXIN)
0.1MG/ML
Marketing Status: Prescription
Active Ingredient: DIGOXIN
Proprietary Name: LANOXIN PEDIATRIC
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N009330
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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