Details for New Drug Application (NDA): 203536
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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 203536
Tradename: | VALSARTAN |
Applicant: | Jubilant Generics |
Ingredient: | valsartan |
Patents: | 0 |
Pharmacology for NDA: 203536
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 203536
Suppliers and Packaging for NDA: 203536
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN | valsartan | TABLET;ORAL | 203536 | ANDA | Medsource Pharmaceuticals | 45865-101 | 45865-101-60 | 60 TABLET in 1 BOTTLE (45865-101-60) |
VALSARTAN | valsartan | TABLET;ORAL | 203536 | ANDA | A-S Medication Solutions | 50090-5190 | 50090-5190-0 | 30 TABLET in 1 BOTTLE (50090-5190-0) |
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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