Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022181
Company: BIOMARIN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KUVAN SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/13/2007 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022181lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022181s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022181TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022181s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/01/2019 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022181Orig1s017ltr.pdf
06/13/2016 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022181s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022181Orig1s014ltr.pdf
04/23/2014 SUPPL-13 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022181s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022181Orig1s013ltr.pdf
11/22/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/19/2013 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022181s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022181Orig1s010ltr.pdf
12/19/2013 SUPPL-9 Efficacy-New Route Of Administration Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022181s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022181Orig1s009ltr.pdf
01/23/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/20/2008 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022181s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s017lbl.pdf
06/13/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022181s014lbl.pdf
04/23/2014 SUPPL-13 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022181s013lbl.pdf
12/19/2013 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022181s010lbl.pdf
12/19/2013 SUPPL-9 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022181s009lbl.pdf
12/13/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022181lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English