Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021164
Company: FABRE KRAMER
Company: FABRE KRAMER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXXUA | GEPIRONE HYDROCHLORIDE | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
| EXXUA | GEPIRONE HYDROCHLORIDE | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| EXXUA | GEPIRONE HYDROCHLORIDE | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| EXXUA | GEPIRONE HYDROCHLORIDE | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/07/2025 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021164Orig1s001lbl.pdf | |
| 09/22/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021164s000lbl.pdf |