Details for New Drug Application (NDA): 078556
✉ Email this page to a colleague
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 078556
Tradename: | DIGOXIN |
Applicant: | Impax Labs |
Ingredient: | digoxin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078556
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIGOXIN | digoxin | TABLET;ORAL | 078556 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-9811 | 0115-9811-01 | 100 TABLET in 1 BOTTLE (0115-9811-01) |
DIGOXIN | digoxin | TABLET;ORAL | 078556 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-9811 | 0115-9811-02 | 500 TABLET in 1 BOTTLE (0115-9811-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.125MG | ||||
Approval Date: | Jul 20, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Jul 20, 2009 | TE: | AB | RLD: | No |
Complete Access Available with Subscription