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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103764
Company: NOVARTIS

Products on BLA 103764

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103764

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.

Labels for BLA 103764

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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