Details for New Drug Application (NDA): 213218
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NDA 213218 describes SOAANZ, which is a drug marketed by Sarfe Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SOAANZ profile page.
The generic ingredient in SOAANZ is torsemide. There are sixteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the torsemide profile page.
The generic ingredient in SOAANZ is torsemide. There are sixteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the torsemide profile page.
Summary for 213218
| Tradename: | SOAANZ |
| Applicant: | Sarfe Pharms |
| Ingredient: | torsemide |
| Patents: | 1 |
Pharmacology for NDA: 213218
| Physiological Effect | Increased Diuresis at Loop of Henle |
Suppliers and Packaging for NDA: 213218
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOAANZ | torsemide | TABLET;ORAL | 213218 | NDA | Sarfez Pharmaceuticals Inc | 73502-287 | 73502-287-16 | 5 BLISTER PACK in 1 CARTON (73502-287-16) / 6 TABLET, FILM COATED in 1 BLISTER PACK (73502-287-12) |
| SOAANZ | torsemide | TABLET;ORAL | 213218 | NDA | Sarfez Pharmaceuticals Inc | 73502-288 | 73502-288-17 | 5 BLISTER PACK in 1 CARTON (73502-288-17) / 6 TABLET, FILM COATED in 1 BLISTER PACK (73502-288-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 14, 2021 | TE: | RLD: | Yes | |||||
| Patent: | 10,154,963 | Patent Expiration: | Oct 6, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Jun 14, 2021 | TE: | RLD: | Yes | |||||
| Patent: | 10,154,963 | Patent Expiration: | Oct 6, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Nov 17, 2021 | TE: | RLD: | Yes | |||||
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