Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103846
Company: ELAN PHARM
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
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
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 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103846s5190lbl.pdf
08/20/2019 SUPPL-5190 Efficacy-New Indication 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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