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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205065
Company: BIOMARIN PHARM

Summary Review

Products on NDA 205065

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205065

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.html 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
08/26/2024	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022181s024,205065s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022181Orig1s024,205065Orig1s008ltr.pdf
12/13/2019	SUPPL-7	Labeling-Package Insert, Labeling-Patient 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-Patient Package Insert, Labeling-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

Labels for NDA 205065

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022181s024,205065s008lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf
12/13/2019	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf
05/02/2019	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf
05/02/2019	SUPPL-5	Labeling-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

Therapeutic Equivalents for NDA 205065

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	215420	ANNORA PHARMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	209452	DR REDDYS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	219511	MICRO LABS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	207207	PH HEALTH
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	216432	TP ANDA HOLDINGS
ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	218645	AUCTA

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	215420	ANNORA PHARMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	215798	DR REDDYS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	219511	MICRO LABS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	210027	PH HEALTH
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	216432	TP ANDA HOLDINGS
ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	218645	AUCTA

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