Details for New Drug Application (NDA): 009330
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NDA 009330 describes LANOXIN PEDIATRIC, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the digoxin profile page.
The generic ingredient in LANOXIN PEDIATRIC is digoxin. There are ten drug master file entries for this compound. Twenty-nine 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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