ALDURAZYME از شرکت BIOMARIN

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALDURAZYME از شرکت BIOMARIN

Biologic License Application (BLA): 125058

Company: BIOMARIN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDURAZYME LARONIDASE 2.9MG/ML 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
04/30/2003 ORIG-1 Approval

N/A; Orphan

Label (PDF)

Letter

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/larobio043003LB.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/larobio043003L.htm
https://web.archive.org/web/20170118085125/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080438.htm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2019 SUPPL-244 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125058s244lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125058Orig1s244ltr.pdf

04/03/2013 SUPPL-220 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125058s220lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125058Orig1s220ltr.pdf

07/13/2011 SUPPL-209 Supplement

Label is not available on this site.

05/14/2010 SUPPL-186 Supplement

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125058s0186lbl.pdf

05/20/2009 SUPPL-161 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s0161ltr.pdf

05/20/2009 SUPPL-160 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s0161ltr.pdf

08/25/2009 SUPPL-158 Supplement

Label is not available on this site.

04/14/2008 SUPPL-154 Supplement

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125058s154ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/04/2019 SUPPL-244

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125058s244lbl.pdf
04/03/2013 SUPPL-220

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125058s220lbl.pdf
05/14/2010 SUPPL-186

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125058s0186lbl.pdf
05/20/2009 SUPPL-161

Efficacy

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf
05/20/2009 SUPPL-160

Efficacy

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf
04/30/2003 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/larobio043003LB.pdf
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