Details for New Drug Application (NDA): 205347
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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 205347
Tradename: | VALSARTAN |
Applicant: | Square Pharms |
Ingredient: | valsartan |
Patents: | 0 |
Pharmacology for NDA: 205347
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 205347
Suppliers and Packaging for NDA: 205347
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN | valsartan | TABLET;ORAL | 205347 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-768 | 10135-768-30 | 30 TABLET in 1 BOTTLE (10135-768-30) |
VALSARTAN | valsartan | TABLET;ORAL | 205347 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-769 | 10135-769-90 | 90 TABLET in 1 BOTTLE (10135-769-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Apr 9, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Apr 9, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Apr 9, 2018 | TE: | AB | RLD: | No |
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