Details for New Drug Application (NDA): 071251
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NDA 071251 describes TRIAMTERENE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Macleods Pharms Ltd, Novartis, Pharmobedient, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon Research, Watson Labs, and Zydus Pharms, and is included in twenty-three NDAs. It is available from twenty-four 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-four 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-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.
Summary for 071251
| Tradename: | TRIAMTERENE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Apotex Inc |
| Ingredient: | hydrochlorothiazide; triamterene |
| Patents: | 0 |
Pharmacology for NDA: 071251
| Physiological Effect | Decreased Renal K+ Excretion Increased Diuresis |
Suppliers and Packaging for NDA: 071251
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; triamterene | TABLET;ORAL | 071251 | ANDA | Golden State Medical Supply, Inc. | 51407-286 | 51407-286-01 | 100 TABLET in 1 BOTTLE (51407-286-01) |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; triamterene | TABLET;ORAL | 071251 | ANDA | Golden State Medical Supply, Inc. | 51407-286 | 51407-286-05 | 500 TABLET in 1 BOTTLE (51407-286-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;75MG | ||||
| Approval Date: | Apr 17, 1988 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;37.5MG | ||||
| Approval Date: | May 5, 1998 | TE: | AB | RLD: | No | ||||
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