Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103634
Company: CENTOCOR INC
Company: CENTOCOR INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYOSCINT | IMCIROMAB PENTETATE | N/A | VIAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/1996 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/imcicen070396-lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/imcicen070396L.htm https://web.archive.org/web/20120303004254/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080665.htm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/03/1996 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/imcicen070396-lab.pdf |