Details for New Drug Application (NDA): 215307
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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.
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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