Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210833
Company: OTTER PHARMS
Company: OTTER PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SYMPAZAN | CLOBAZAM | 5MG | FILM;ORAL | Prescription | None | Yes | No |
SYMPAZAN | CLOBAZAM | 10MG | FILM;ORAL | Prescription | None | Yes | No |
SYMPAZAN | CLOBAZAM | 20MG | FILM;ORAL | 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 |
---|---|---|---|---|---|---|---|
11/01/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210833s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210833Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210833Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/12/2024 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210833s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210833Orig1s006ltr.pdf | |
01/13/2023 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210833s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210833Orig1s004ltr.pdf | |
02/05/2021 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210833Orig1s003ltr.pdf | |
03/16/2021 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210833Orig1s002ltr.pdf | |
12/09/2020 | SUPPL-1 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210833Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/12/2024 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210833s006lbl.pdf | |
01/13/2023 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210833s004lbl.pdf | |
03/16/2021 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s002lbl.pdf | |
02/05/2021 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s003lbl.pdf | |
11/01/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210833s000lbl.pdf |