Details for New Drug Application (NDA): 214982
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NDA 214982 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-six 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 214982
| Tradename: | DIGOXIN |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | digoxin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214982
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIGOXIN | digoxin | TABLET;ORAL | 214982 | ANDA | A-S Medication Solutions | 50090-6708 | 50090-6708-1 | 100 TABLET in 1 BOTTLE (50090-6708-1) |
| DIGOXIN | digoxin | TABLET;ORAL | 214982 | ANDA | AvPAK | 50268-238 | 50268-238-15 | 50 BLISTER PACK in 1 BOX (50268-238-15) / 1 TABLET in 1 BLISTER PACK (50268-238-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.0625MG | ||||
| Approval Date: | Feb 8, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Feb 8, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Feb 8, 2022 | TE: | AB | RLD: | No | ||||
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