Details for New Drug Application (NDA): 013174
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NDA 013174 describes DYRENIUM, which is a drug marketed by Advanz Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the DYRENIUM profile page.
The generic ingredient in DYRENIUM is triamterene. There are seventeen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the triamterene profile page.
The generic ingredient in DYRENIUM is triamterene. There are seventeen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the triamterene profile page.
Summary for 013174
| Tradename: | DYRENIUM |
| Applicant: | Advanz Pharma |
| Ingredient: | triamterene |
| Patents: | 0 |
Pharmacology for NDA: 013174
| Physiological Effect | Decreased Renal K+ Excretion Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 013174
Suppliers and Packaging for NDA: 013174
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DYRENIUM | triamterene | CAPSULE;ORAL | 013174 | NDA | Advanz Pharma (US) Corp. | 59212-002 | 59212-002-01 | 100 CAPSULE in 1 BOTTLE (59212-002-01) |
| DYRENIUM | triamterene | CAPSULE;ORAL | 013174 | NDA | Advanz Pharma (US) Corp. | 59212-003 | 59212-003-01 | 100 CAPSULE in 1 BOTTLE (59212-003-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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