Details for New Drug Application (NDA): 091367
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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.
Pharmacology for NDA: 091367
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 091367
Suppliers and Packaging for NDA: 091367
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN | valsartan | TABLET;ORAL | 091367 | ANDA | Medsource Pharmaceuticals | 45865-114 | 45865-114-60 | 60 TABLET in 1 BOTTLE (45865-114-60) |
VALSARTAN | valsartan | TABLET;ORAL | 091367 | ANDA | Alembic Pharmaceuticals Limited | 46708-044 | 46708-044-10 | 100 TABLET in 1 CARTON (46708-044-10) |
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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