Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103764
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

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