Details for New Drug Application (NDA): 076268
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The generic ingredient in DIGOXIN 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 076268
Tradename: | DIGOXIN |
Applicant: | Stevens J |
Ingredient: | digoxin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076268
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIGOXIN | digoxin | TABLET;ORAL | 076268 | ANDA | Lannett Company, Inc. | 0527-1324 | 0527-1324-01 | 100 TABLET in 1 BOTTLE (0527-1324-01) |
DIGOXIN | digoxin | TABLET;ORAL | 076268 | ANDA | Lannett Company, Inc. | 0527-1324 | 0527-1324-10 | 1000 TABLET in 1 BOTTLE (0527-1324-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.125MG | ||||
Approval Date: | Jul 26, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Jul 26, 2002 | TE: | AB | RLD: | No |
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