Details for New Drug Application (NDA): 207896
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The generic ingredient in IRBESARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for 207896
Tradename: | IRBESARTAN AND HYDROCHLOROTHIAZIDE |
Applicant: | Hisun Pharm Hangzhou |
Ingredient: | hydrochlorothiazide; irbesartan |
Patents: | 0 |
Pharmacology for NDA: 207896
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 207896
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 207896 | ANDA | Hisun Pharmaceuticals USA Inc. | 42658-141 | 42658-141-01 | 30 TABLET, FILM COATED in 1 BOTTLE (42658-141-01) |
IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 207896 | ANDA | Hisun Pharmaceuticals USA Inc. | 42658-141 | 42658-141-04 | 90 TABLET, FILM COATED in 1 BOTTLE (42658-141-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;150MG | ||||
Approval Date: | Oct 14, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;300MG | ||||
Approval Date: | Oct 14, 2016 | TE: | AB | RLD: | No |
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