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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103846
Company: ELAN PHARM

Medication Guide

Other Important Information from FDA

Products on BLA 103846

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYOBLOC	Botulinum Toxin Type B	5000IU/VIAL	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103846

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2000	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/botelan120800lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/botelan120800L.htm https://web.archive.org/web/20170201030814/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080661.htm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/10/2021	SUPPL-5195	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103846s5195lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103846Orig1s5195ltr.pdf
08/20/2019	SUPPL-5190	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103846s5190lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103846Orig1s5190ltr.pdf
06/13/2012	SUPPL-5156	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103846s5156ltr.pdf
07/31/2009	SUPPL-5120	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103846s5120lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103846s5120ltr.pdf

Labels for BLA 103846

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/10/2021	SUPPL-5195	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103846s5195lbl.pdf
03/10/2021	SUPPL-5195	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103846s5195lbl.pdf
08/20/2019	SUPPL-5190	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103846s5190lbl.pdf
08/20/2019	SUPPL-5190	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103846s5190lbl.pdf
07/31/2009	SUPPL-5120	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103846s5120lbl.pdf
12/08/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/botelan120800lb.pdf

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