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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020405

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LANOXIN (DIGOXIN)
0.0625MG
Marketing Status: Prescription
Active Ingredient: DIGOXIN
Proprietary Name: LANOXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.0625MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020405
Product Number: 001
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LANOXIN (DIGOXIN)
0.125MG
Marketing Status: Prescription
Active Ingredient: DIGOXIN
Proprietary Name: LANOXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020405
Product Number: 002
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LANOXIN (DIGOXIN)
0.25MG
Marketing Status: Prescription
Active Ingredient: DIGOXIN
Proprietary Name: LANOXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020405
Product Number: 004
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LANOXIN (DIGOXIN)
0.1875MG
Marketing Status: Discontinued
Active Ingredient: DIGOXIN
Proprietary Name: LANOXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.1875MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020405
Product Number: 003
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LANOXIN (DIGOXIN)
0.375MG
Marketing Status: Discontinued
Active Ingredient: DIGOXIN
Proprietary Name: LANOXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.375MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020405
Product Number: 005
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LANOXIN (DIGOXIN)
0.5MG
Marketing Status: Discontinued
Active Ingredient: DIGOXIN
Proprietary Name: LANOXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020405
Product Number: 006
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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