Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103764
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIMULECT | BASILIXIMAB | 10MG | VIAL; SINGLE-USE | Prescription | None | No | No |
SIMULECT | BASILIXIMAB | 20MG | VIAL; SINGLE-USE | Prescription | 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 |
---|---|---|---|---|---|---|---|
05/12/1998 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/basnov051298lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/basnov051298L.htm https://web.archive.org/web/20170113111552/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093359.htm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/15/2005 | SUPPL-5059 | Supplement |
Label is not available on this site. |
||
05/27/2003 | SUPPL-5046 | Supplement |
Label is not available on this site. |
||
11/14/2003 | SUPPL-5040 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103764-5040ltr.pdf |
01/02/2003 | SUPPL-5037 | Supplement |
Label
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/basnov010203LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/basnov010203L.htm | |
11/29/2001 | SUPPL-5006 | Supplement |
Label is not available on this site. |
||
03/23/2001 | SUPPL-5003 | Supplement |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/basnova032301LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/basnova032301L.htm | |
03/22/2001 | SUPPL-1010 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/02/2003 | SUPPL-5037 | Supplement | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/basnov010203LB.htm | ||
03/23/2001 | SUPPL-5003 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/basnova032301LB.pdf | |
05/12/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/basnov051298lb.pdf |