Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 217006
Company: OTSUKA
Company: OTSUKA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABILIFY ASIMTUFII | ARIPIPRAZOLE | 720MG/2.4ML (300MG/ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | No |
| ABILIFY ASIMTUFII | ARIPIPRAZOLE | 960MG/3.2ML (300MG/ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/27/2023 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217006s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217006Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217006Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/27/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217006s000lbl.pdf |