| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 213004 | NDA | REDHILL | 001 | TALICIA | CAPSULE, DELAYED RELEASE;ORAL | 250MG;EQ 10MG BASE;12.5MG | AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN | 2019-11-01 | Prescription | Yes |