Details for New Drug Application (NDA): 021648
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The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 021648
Tradename: | DIGOXIN |
Applicant: | Hikma |
Ingredient: | digoxin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021648
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIGOXIN | digoxin | ELIXIR;ORAL | 021648 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0057 | 0054-0057-46 | 60 mL in 1 BOTTLE (0054-0057-46) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | ELIXIR;ORAL | Strength | 0.05MG/ML | ||||
Approval Date: | Aug 26, 2004 | TE: | AA | RLD: | Yes |
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