Details for New Drug Application (NDA): 083391
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The generic ingredient in DIGOXIN 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.
Suppliers and Packaging for NDA: 083391
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIGOXIN | digoxin | INJECTABLE;INJECTION | 083391 | ANDA | Henry Schein, Inc. | 0404-9850 | 0404-9850-02 | 1 AMPULE in 1 BAG (0404-9850-02) / 2 mL in 1 AMPULE |
DIGOXIN | digoxin | INJECTABLE;INJECTION | 083391 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-1410 | 0641-1410-35 | 25 AMPULE in 1 CARTON (0641-1410-35) / 2 mL in 1 AMPULE (0641-1410-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No |
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