Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206088
Company: CELGENE CORP
Company: CELGENE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OTEZLA | APREMILAST | 10MG | TABLET;ORAL | Prescription | TBD | TBD | No |
OTEZLA | APREMILAST | 20MG | TABLET;ORAL | Prescription | TBD | TBD | No |
OTEZLA | APREMILAST | 30MG | TABLET;ORAL | Prescription | TBD | TBD | 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 |
---|---|---|---|---|---|---|---|
09/23/2014 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206088s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206088Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000SumR.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/23/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206088s000lbl.pdf |
OTEZLA
There are no Therapeutic Equivalents.