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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022181
Company: BIOMARIN PHARM

Questions and Answers

Summary Review

Products on NDA 022181

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KUVAN	SAPROPTERIN DIHYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022181

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.html 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
08/26/2024	SUPPL-24	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
03/16/2020	SUPPL-20	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-19	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
12/13/2019	SUPPL-18	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/2019/022181Orig1s018,205056Orig1s007ltr.pdf
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/2022/022181s014lbl.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

Labels for NDA 022181

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2024	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022181s024,205065s008lbl.pdf
03/16/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022181s020,205065s006lbl.pdf
12/13/2019	SUPPL-18	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf
12/13/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf
05/02/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf
05/02/2019	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf
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/2022/022181s014lbl.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

Therapeutic Equivalents for NDA 022181

KUVAN

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KUVAN	SAPROPTERIN DIHYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	Yes	AB	022181	BIOMARIN PHARM
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	215534	ANNORA PHARMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	216797	AUROBINDO PHARMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207685	DR REDDYS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	218797	HIKMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207200	PH HEALTH

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