Details for New Drug Application (NDA): 215307
✉ Email this page to a colleague
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.
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 |
Complete Access Available with Subscription