Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205065
Company: BIOMARIN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KUVAN SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER;ORAL Prescription AB Yes Yes
KUVAN SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER;ORAL Prescription AB Yes 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
12/19/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205065Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2019 SUPPL-7 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022181Orig1s018,205065Orig1s007ltr.pdf
03/16/2020 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022181s020,205065s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022181Orig1s020, 205065Orig1s006ltr.pdf
05/02/2019 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022181Orig1s019, 205065Orig1s005ltr.pdf
08/09/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205065s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205065Orig1s002ltr.pdf
10/28/2015 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/16/2020 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022181s020,205065s006lbl.pdf
12/13/2019 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf
12/13/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf
05/02/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf
05/02/2019 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf
08/09/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205065s002lbl.pdf
10/28/2015 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf
12/19/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf

KUVAN

POWDER;ORAL; 100MG/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KUVAN SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER;ORAL Prescription Yes AB 205065 BIOMARIN PHARM
SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET POWDER;ORAL Prescription No AB 207207 PAR PHARM INC

POWDER;ORAL; 500MG/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KUVAN SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER;ORAL Prescription Yes AB 205065 BIOMARIN PHARM
SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET POWDER;ORAL Prescription No AB 210027 PAR PHARM INC

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