Details for New Drug Application (NDA): 077002
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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 077002
Tradename: | DIGOXIN |
Applicant: | Hikma Intl Pharms |
Ingredient: | digoxin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077002
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIGOXIN | digoxin | TABLET;ORAL | 077002 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-1240 | 0143-1240-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0143-1240-01) |
DIGOXIN | digoxin | TABLET;ORAL | 077002 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-1240 | 0143-1240-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1240-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Oct 30, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.125MG | ||||
Approval Date: | Oct 30, 2007 | TE: | AB | RLD: | No |
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