Details for New Drug Application (NDA): 214768
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NDA 214768 describes TRIAMTERENE, which is a drug marketed by Agnitio, Biocon Generics, Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Macleods Pharms Ltd, Norvium Bioscience, Novartis, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon, Watson Labs, and Zydus Pharms, and is included in twenty-five NDAs. It is available from three 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-four 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-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.
Summary for 214768
| Tradename: | TRIAMTERENE |
| Applicant: | Biocon Generics |
| Ingredient: | triamterene |
| Patents: | 0 |
Pharmacology for NDA: 214768
| Physiological Effect | Decreased Renal K+ Excretion Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 214768
Suppliers and Packaging for NDA: 214768
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIAMTERENE | triamterene | CAPSULE;ORAL | 214768 | ANDA | Biocon Pharma Inc. | 70377-138 | 70377-138-11 | 30 CAPSULE in 1 BOTTLE (70377-138-11) |
| TRIAMTERENE | triamterene | CAPSULE;ORAL | 214768 | ANDA | Biocon Pharma Inc. | 70377-138 | 70377-138-12 | 100 CAPSULE in 1 BOTTLE (70377-138-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 6, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 6, 2022 | TE: | AB | RLD: | No | ||||
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