Details for New Drug Application (NDA): 209139
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The generic ingredient in PREXXARTAN is valsartan. There are forty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the valsartan profile page.
Summary for 209139
Tradename: | PREXXARTAN |
Applicant: | Carmel Biosciences |
Ingredient: | valsartan |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 209139
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 19, 2017 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 19, 2017 | TE: | RLD: | Yes |
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