Details for New Drug Application (NDA): 090866
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The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 090866
Tradename: | VALSARTAN |
Applicant: | Mylan |
Ingredient: | valsartan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090866
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090866
Suppliers and Packaging for NDA: 090866
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN | valsartan | TABLET;ORAL | 090866 | ANDA | Mylan Pharmaceuticals Inc. | 0378-5807 | 0378-5807-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5807-93) |
VALSARTAN | valsartan | TABLET;ORAL | 090866 | ANDA | Mylan Pharmaceuticals Inc. | 0378-5813 | 0378-5813-77 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5813-77) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jan 5, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Jan 5, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Jan 5, 2015 | TE: | AB | RLD: | No |
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