Details for New Drug Application (NDA): 210709
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NDA 210709 describes TEKTURNA, which is a drug marketed by Noden Pharma and is included in three NDAs. It is available from three suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TEKTURNA profile page.
The generic ingredient in TEKTURNA is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
The generic ingredient in TEKTURNA is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
Summary for 210709
| Tradename: | TEKTURNA |
| Applicant: | Noden Pharma |
| Ingredient: | aliskiren hemifumarate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, PELLET;ORAL | Strength | EQ 37.5MG BASE | ||||
| Approval Date: | Nov 14, 2017 | TE: | RLD: | Yes | |||||
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