approval · primary record
AMLODIPINE BESYLATE
3 approval events · latest 2026-05-28
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-05-28 |
| Approval events | 3 |
| Brand | WIDAPLIK |
| Sponsor | AZURITY |
| Route | ORAL |
Approval history
3 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-05-28 | FDA | NDA | WIDAPLIK | AZURITY | ORAL |
| 2026-05-08 | FDA | NDA | SDAMLO | BRILLIAN PHARMA | ORAL |
| 2024-11-04 | FDA | NDA | CADUET | PHARMACIA | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:31:23.686Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:amlodipine-besylate
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Amlodipine Besylate · compound