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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 219531


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NDA 219531 describes SDAMLO, which is a drug marketed by Brillian Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the SDAMLO profile page.

The generic ingredient in SDAMLO is amlodipine besylate. There are fifty drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.
Summary for 219531
Tradename:SDAMLO
Applicant:Brillian Pharma
Ingredient:amlodipine besylate
Patents:0
Pharmacology for NDA: 219531
Mechanism of ActionCalcium Channel Antagonists
Cytochrome P450 3A Inhibitors
Suppliers and Packaging for NDA: 219531
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SDAMLO amlodipine besylate FOR SOLUTION;ORAL 219531 NDA Pangea Pharmaceuticals, LLC 81279-133 81279-133-10 10 BOTTLE in 1 CARTON (81279-133-10) / 2.5 mg in 1 BOTTLE
SDAMLO amlodipine besylate FOR SOLUTION;ORAL 219531 NDA Pangea Pharmaceuticals, LLC 81279-134 81279-134-10 10 BOTTLE in 1 CARTON (81279-134-10) / 5 mg in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 2.5MG BASE/BOT
Approval Date:Jul 24, 2025TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 5MG BASE/BOT
Approval Date:Jul 24, 2025TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 10MG BASE/BOT
Approval Date:Jul 24, 2025TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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