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. Thirty 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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