Details for New Drug Application (NDA): 204011
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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 204011
Tradename: | VALSARTAN |
Applicant: | Amneal Pharms |
Ingredient: | valsartan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204011
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 204011
Suppliers and Packaging for NDA: 204011
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN | valsartan | TABLET;ORAL | 204011 | ANDA | AvKARE | 42291-856 | 42291-856-30 | 30 TABLET in 1 BOTTLE (42291-856-30) |
VALSARTAN | valsartan | TABLET;ORAL | 204011 | ANDA | AvKARE | 42291-857 | 42291-857-90 | 90 TABLET in 1 BOTTLE (42291-857-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jan 11, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Jan 11, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Jan 11, 2016 | TE: | AB | RLD: | No |
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