Details for New Drug Application (NDA): 216211
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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 216211
Tradename: | TRIAMTERENE AND HYDROCHLOROTHIAZIDE |
Applicant: | Rubicon |
Ingredient: | hydrochlorothiazide; triamterene |
Patents: | 0 |
Pharmacology for NDA: 216211
Physiological Effect | Decreased Renal K+ Excretion Increased Diuresis |
Suppliers and Packaging for NDA: 216211
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; triamterene | TABLET;ORAL | 216211 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8624 | 68788-8624-1 | 100 TABLET in 1 BOTTLE (68788-8624-1) |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; triamterene | TABLET;ORAL | 216211 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8624 | 68788-8624-3 | 30 TABLET in 1 BOTTLE (68788-8624-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;37.5MG | ||||
Approval Date: | Feb 23, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;75MG | ||||
Approval Date: | Feb 23, 2022 | TE: | AB | RLD: | No |
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