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https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg
11 months ago -
...voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral...Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride ...
https://www.fda.gov/media/169172/download
about 8 years ago -
Epidemiology-II (DEPI-II) Product Name: Kuvan (sapropterin dihydrochloride) Pediatric Labeling...drug utilization data for Kuvan (sapropterin ...
https://www.fda.gov/drugs/first-generic-drug-approvals/2019-first-generic-drug-approvals
over 1 year ago -
...severely immunocompromised 79 210027 Sapropterin Dihydrochloride Powder for Oral...Par Pharmaceutical, Inc. Kuvan (Sapropterin Dihydrochloride) Powder ...
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/august-5-2022-posting-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
8 months ago -
Information (as of July 20, 2022) Kuvan (sapropterin dihydrochloride) Gastric ulcer The
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cder-nitrosamine-impurity-acceptable-intake-limits
11 days ago -
N-nitroso-sapropterin-1 Sapropterin 4 1500 ng/day N-nitroso-sapropterin-2 Sapropterin
https://www.fda.gov/advisory-committees/pediatric-advisory-committee/presentations-march-6-7-2017-meeting-pediatric-advisory-committee
about 2 years ago -
CDER Exjade (deferasirox) Kuvan (sapropterin dihydrochloride) Nitropress (sodium
https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-6-2017-pediatric-advisory-committee-meeting-announcement-03062017
about 1 year ago -
...(sodium nitroprusside), and KUVAN (sapropterin dihydrochloride). The FDA will provide
https://www.fda.gov/media/88344/download
almost 11 years ago -
...22181 Sapropterin Amendment...22181 Sapropterin Amendment DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and...Study Request (PPSR) for Kuvan (sapropter ...
https://www.fda.gov/media/88384/download
almost 11 years ago -
N22-181 S013 Sapropterin Clinical BPCA...N22-181 S013 Sapropterin Clinical BPCA CLINICAL REVIEW Application Type NDA...Date March 6, 2014 Established ...
https://www.fda.gov/media/88338/download
almost 11 years ago -
...22181 Sapropterin Written Request...22181 Sapropterin Written Request DEPARTMENT OF HEALTH & HUMAN SERVICES Public...Pediatric Study Request for ...
https://www.fda.gov/drugs/development-resources/list-determinations-including-written-request
19 days ago -
...- 168KB] Amendment [PDF - 239KB] Sapropterin BioMarin 3/13/2014 Written Request
https://www.fda.gov/media/88392/download
almost 11 years ago -
N22-181 S013 Sapropterin Clinpharm BPCA...N22-181 S013 Sapropterin Clinpharm BPCA (b) (4) OFFICE OF CLINICAL PHARMACOLOGY...2/13/2014 Brand Name Kuvan ...
https://www.fda.gov/media/103563/download
about 8 years ago -
Kuvan (sapropterin dihhydrochloride)...Pediatric-Focused Safety Review: Kuvan (sapropterin dihhydrochloride) Pediatric Advisory...Pediatric-Focused ...
https://www.fda.gov/media/180157/download
over 6 years ago -
...(DCM) Salmeterol 3/9/06 GSK Asthma Sapropterin 3/13/14 BioMarin Reduce blood phenylalanine
https://www.fda.gov/media/182650/download
over 8 years ago -
Salmeterol Glaxo Wellcome, Inc. 5/20/99 Sapropterin BioMarin Pharmaceutical, Inc. 1/14/08
https://www.fda.gov/media/134156/download
over 8 years ago -
Salmeterol Glaxo Wellcome, Inc. 5/20/99 Sapropterin BioMarin Pharmaceutical, Inc. 1/14/08
https://www.fda.gov/media/178811/download
almost 3 years ago -
...mild Sapropterin Dihydrochloride SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE
https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development
4 months ago -
Within the next 12 months No change Sapropterin Dihydrochloride Oral Powder 205065
https://www.fda.gov/media/71494/download
2 months ago -
KURVELO, ETHINYL ESTRADIOL KUVAN, SAPROPTERIN DIHYDROCHLORIDE KYBELLA, DEOXYCHOLIC...ASENAPINE MALEATE SAPROPTERIN DIHYDROCHLORIDE, SAPROPTERIN ...
https://www.fda.gov/media/161516/download
over 2 years ago -
...2022 Aug Aug Aug NFTG NEWA NEWA SAPROPTERIN DIHYDROCHLORIDE >A> >A> >A> AB AB...POWDER;ORAL SAPROPTERIN DIHYDROCHLORIDE ANNORA PHARMA TABLET;ORAL SAPR ...
