Details for New Drug Application (NDA): 078020
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The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 078020
Tradename: | VALSARTAN AND HYDROCHLOROTHIAZIDE |
Applicant: | Mylan Pharms Inc |
Ingredient: | hydrochlorothiazide; valsartan |
Patents: | 0 |
Pharmacology for NDA: 078020
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 078020
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; valsartan | TABLET;ORAL | 078020 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6321 | 0378-6321-77 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6321-77) |
VALSARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; valsartan | TABLET;ORAL | 078020 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6322 | 0378-6322-77 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6322-77) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;80MG | ||||
Approval Date: | Sep 21, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;160MG | ||||
Approval Date: | Sep 21, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;160MG | ||||
Approval Date: | Sep 21, 2012 | TE: | AB | RLD: | No |
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