Details for New Drug Application (NDA): 009330
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The generic ingredient in LANOXIN PEDIATRIC is digoxin. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 009330
Tradename: | LANOXIN PEDIATRIC |
Applicant: | Covis |
Ingredient: | digoxin |
Patents: | 0 |
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 Pharma US, Inc | 70515-260 | 70515-260-10 | 10 AMPULE in 1 BOX (70515-260-10) / 2 mL in 1 AMPULE |
LANOXIN | digoxin | INJECTABLE;INJECTION | 009330 | NDA | Covis Pharma US, Inc | 70515-261 | 70515-261-10 | 10 VIAL in 1 BOX (70515-261-10) / 2 mL in 1 VIAL |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.1MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
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