Details for New Drug Application (NDA): 208360
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NDA 208360 describes TRIAMTERENE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by 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-two NDAs. It is available from twenty-nine suppliers. Additional details are available on the TRIAMTERENE AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in TRIAMTERENE AND HYDROCHLOROTHIAZIDE 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 AND HYDROCHLOROTHIAZIDE 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 208360
| Tradename: | TRIAMTERENE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | hydrochlorothiazide; triamterene |
| Patents: | 0 |
Pharmacology for NDA: 208360
| Physiological Effect | Decreased Renal K+ Excretion Increased Diuresis |
Suppliers and Packaging for NDA: 208360
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; triamterene | TABLET;ORAL | 208360 | ANDA | A-S Medication Solutions | 50090-5801 | 50090-5801-0 | 30 TABLET in 1 BOTTLE (50090-5801-0) |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; triamterene | TABLET;ORAL | 208360 | ANDA | A-S Medication Solutions | 50090-5801 | 50090-5801-1 | 100 TABLET in 1 BOTTLE (50090-5801-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;37.5MG | ||||
| Approval Date: | Jun 29, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;75MG | ||||
| Approval Date: | Jun 29, 2018 | TE: | AB | RLD: | No | ||||
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