Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212268
Company: HISAMITSU
Company: HISAMITSU
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SECUADO | ASENAPINE | 3.8MG/24HR | SYSTEM;TRANSDERMAL | Prescription | None | Yes | Yes |
| SECUADO | ASENAPINE | 5.7MG/24HR | SYSTEM;TRANSDERMAL | Prescription | None | Yes | No |
| SECUADO | ASENAPINE | 7.6MG/24HR | SYSTEM;TRANSDERMAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/11/2019 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212268s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212268Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212268Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/11/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212268s000lbl.pdf |