Details for New Drug Application (NDA): 202696
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The generic ingredient in VALSARTAN 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 202696
Tradename: | VALSARTAN |
Applicant: | Macleods Pharms Ltd |
Ingredient: | valsartan |
Patents: | 0 |
Pharmacology for NDA: 202696
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 202696
Suppliers and Packaging for NDA: 202696
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN | valsartan | TABLET;ORAL | 202696 | ANDA | Macleods Pharmaceuticals Limited | 33342-062 | 33342-062-07 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-062-07) |
VALSARTAN | valsartan | TABLET;ORAL | 202696 | ANDA | Macleods Pharmaceuticals Limited | 33342-062 | 33342-062-44 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-062-44) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Sep 16, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Sep 16, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Sep 16, 2016 | TE: | AB | RLD: | No |
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