Details for New Drug Application (NDA): 214102
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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 214102
Tradename: | VALSARTAN |
Applicant: | Novitium Pharma |
Ingredient: | valsartan |
Patents: | 0 |
Pharmacology for NDA: 214102
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 214102
Suppliers and Packaging for NDA: 214102
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALSARTAN | valsartan | SOLUTION;ORAL | 214102 | ANDA | ANI Pharmaceuticals, Inc. | 70954-310 | 70954-310-10 | 120 mL in 1 BOTTLE, PLASTIC (70954-310-10) |
VALSARTAN | valsartan | SOLUTION;ORAL | 214102 | ANDA | ANI Pharmaceuticals, Inc. | 70954-310 | 70954-310-20 | 473 mL in 1 BOTTLE, PLASTIC (70954-310-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 20MG/5ML | ||||
Approval Date: | Nov 2, 2021 | TE: | RLD: | No |
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