Details for New Drug Application (NDA): 219531
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The generic ingredient in SDAMLO is amlodipine besylate. There are fifty drug master file entries for this compound. Forty-four 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 2.5MG BASE/BOT | ||||
| Approval Date: | Jul 24, 2025 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 5MG BASE/BOT | ||||
| Approval Date: | Jul 24, 2025 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 10MG BASE/BOT | ||||
| Approval Date: | Jul 24, 2025 | TE: | RLD: | Yes | |||||
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