Details for New Drug Application (NDA): 215307
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NDA 215307 describes DIGOXIN, which is a drug marketed by Amici Pharma, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, 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-seven 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. Thirty 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. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 215307
| Tradename: | DIGOXIN |
| Applicant: | Novitium Pharma |
| Ingredient: | digoxin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215307
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIGOXIN | digoxin | TABLET;ORAL | 215307 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-747 | 10135-747-01 | 100 TABLET in 1 BOTTLE (10135-747-01) |
| DIGOXIN | digoxin | TABLET;ORAL | 215307 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-747 | 10135-747-10 | 1000 TABLET in 1 BOTTLE (10135-747-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Nov 22, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Nov 22, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.0625MG | ||||
| Approval Date: | Aug 25, 2022 | TE: | AB | RLD: | No | ||||
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