Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213586
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
UZEDY | RISPERIDONE | 50MG/0.14ML (50MG/0.14ML) | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Prescription | None | Yes | No |
UZEDY | RISPERIDONE | 75MG/0.21ML (75MG/0.21ML) | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Prescription | None | Yes | No |
UZEDY | RISPERIDONE | 100MG/0.28ML (100MG/0.28ML) | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Prescription | None | Yes | No |
UZEDY | RISPERIDONE | 125MG/0.35ML (125MG/0.35ML) | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Prescription | None | Yes | No |
UZEDY | RISPERIDONE | 150MG/0.42ML (150MG/0.42ML) | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Prescription | None | Yes | No |
UZEDY | RISPERIDONE | 200MG/0.56ML (200MG/0.56ML) | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Prescription | None | Yes | No |
UZEDY | RISPERIDONE | 250MG/0.7ML (250MG/0.7ML) | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
04/28/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213586s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213586Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/213586Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/01/2023 | SUPPL-1 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213586Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213586s000lbl.pdf |