Details for New Drug Application (NDA): 079234
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NDA 079234 describes TORSEMIDE, which is a drug marketed by Am Regent, Hikma, Aurobindo Pharma, Corepharma, Hetero Labs Ltd Iii, Pliva Pharm Ind, Strides Pharma Intl, Sun Pharm Inds, and Teva, and is included in eleven NDAs. It is available from twenty-one suppliers. Additional details are available on the TORSEMIDE profile page.
The generic ingredient in TORSEMIDE is torsemide. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the torsemide profile page.
The generic ingredient in TORSEMIDE is torsemide. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the torsemide profile page.
Summary for 079234
| Tradename: | TORSEMIDE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | torsemide |
| Patents: | 0 |
Pharmacology for NDA: 079234
| Physiological Effect | Increased Diuresis at Loop of Henle |
Suppliers and Packaging for NDA: 079234
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TORSEMIDE | torsemide | TABLET;ORAL | 079234 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7997 | 0615-7997-05 | 15 TABLET in 1 BLISTER PACK (0615-7997-05) |
| TORSEMIDE | torsemide | TABLET;ORAL | 079234 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7997 | 0615-7997-39 | 30 TABLET in 1 BLISTER PACK (0615-7997-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 27, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 27, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jan 27, 2009 | TE: | AB | RLD: | No | ||||
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