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. It is available from one supplier. 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 |
Pharmacology for NDA: 209139
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 209139
Suppliers and Packaging for NDA: 209139
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREXXARTAN | valsartan | SOLUTION;ORAL | 209139 | NDA | AptaPharma Inc. | 76281-155 | 76281-155-56 | 20 mL in 1 CUP, UNIT-DOSE (76281-155-56) |
| PREXXARTAN | valsartan | SOLUTION;ORAL | 209139 | NDA | AptaPharma Inc. | 76281-155 | 76281-155-64 | 120 mL in 1 BOTTLE (76281-155-64) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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