Details for New Drug Application (NDA): 218772
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NDA 218772 describes ARBLI, which is a drug marketed by Scienture and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ARBLI profile page.
The generic ingredient in ARBLI is losartan potassium. There are thirty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the losartan potassium profile page.
The generic ingredient in ARBLI is losartan potassium. There are thirty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the losartan potassium profile page.
Summary for 218772
| Tradename: | ARBLI |
| Applicant: | Scienture |
| Ingredient: | losartan potassium |
| Patents: | 2 |
Pharmacology for NDA: 218772
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 218772
Suppliers and Packaging for NDA: 218772
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARBLI | losartan potassium | SUSPENSION;ORAL | 218772 | NDA | Scienture LLC | 83245-053 | 83245-053-06 | 1 BOTTLE in 1 CARTON (83245-053-06) / 165 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Mar 13, 2025 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 7, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 7, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF USING LOSARTAN FOR THE REDUCTION OF THE RISK OF STROKE IN PATIENTS WITH HYPERTENSION AND LEFT VENTRICULAR HYPERTROPHY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 7, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF USING LOSARTAN FOR THE TREATMENT OF DIABETIC NEPHROPATHY WITH AN ELEVATED SERUM CREATININE AND PROTEINURIA IN PATIENTS WITH TYPE 2 DIABETES AND A HISTORY OF HYPERTENSION | ||||||||
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