Details for New Drug Application (NDA): 205536
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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 205536
Tradename: | VALSARTAN |
Applicant: | Alkem Labs Ltd |
Ingredient: | valsartan |
Patents: | 0 |
Pharmacology for NDA: 205536
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 205536
Suppliers and Packaging for NDA: 205536
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN | valsartan | TABLET;ORAL | 205536 | ANDA | American Health Packaging | 60687-612 | 60687-612-21 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-612-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-612-11) |
VALSARTAN | valsartan | TABLET;ORAL | 205536 | ANDA | American Health Packaging | 60687-623 | 60687-623-01 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-623-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-623-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Mar 12, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Mar 12, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Mar 12, 2019 | TE: | AB | RLD: | No |
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