Details for New Drug Application (NDA): 209139
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NDA 209139 describes PREXXARTAN, which is a drug marketed by Carmel Biosciences and is included in one NDA. Additional details are available on the PREXXARTAN profile page.
The generic ingredient in PREXXARTAN is valsartan. There are forty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the valsartan profile page.
The generic ingredient in PREXXARTAN is valsartan. There are forty drug master file entries for this compound. Thirty-five 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| Dosage: | SOLUTION;ORAL | Strength | 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| Dosage: | SOLUTION;ORAL | Strength | 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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