Details for New Drug Application (NDA): 211581
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NDA 211581 describes TRIAMTERENE, which is a drug marketed by Agnitio, Hibrow Hlthcare, Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Norvium Bioscience, Novartis, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon, Watson Labs, and Zydus Pharms, and is included in twenty-four NDAs. It is available from two suppliers. Additional details are available on the TRIAMTERENE profile page.
The generic ingredient in TRIAMTERENE is hydrochlorothiazide; triamterene. There are thirty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.
The generic ingredient in TRIAMTERENE is hydrochlorothiazide; triamterene. There are thirty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.
Summary for 211581
| Tradename: | TRIAMTERENE |
| Applicant: | Agnitio |
| Ingredient: | triamterene |
| Patents: | 0 |
Pharmacology for NDA: 211581
| Physiological Effect | Decreased Renal K+ Excretion Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 211581
Suppliers and Packaging for NDA: 211581
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIAMTERENE | triamterene | CAPSULE;ORAL | 211581 | ANDA | TRUPHARMA LLC | 52817-364 | 52817-364-10 | 100 CAPSULE in 1 BOTTLE (52817-364-10) |
| TRIAMTERENE | triamterene | CAPSULE;ORAL | 211581 | ANDA | TRUPHARMA LLC | 52817-365 | 52817-365-10 | 100 CAPSULE in 1 BOTTLE (52817-365-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No | ||||
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