Details for New Drug Application (NDA): 083391
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NDA 083391 describes DIGOXIN, which is a drug marketed by Amici, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, West-ward Pharms Int, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, Rising, Stevens J, and Sun Pharm Inds Inc, and is included in seventeen NDAs. It is available from twenty-five suppliers. Additional details are available on the DIGOXIN profile page.
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.
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 083391
| Tradename: | DIGOXIN |
| Applicant: | West-ward Pharms Int |
| Ingredient: | digoxin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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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