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Suppliers and packages for generic ingredient: sapropterin dihydrochloride

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Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065NDABioMarin Pharmaceutical Inc.68135-301-2230 PACKET in 1 CARTON (68135-301-22) > 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11)
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065NDABioMarin Pharmaceutical Inc.68135-482-1130 PACKET in 1 CARTON (68135-482-11) > 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10)
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181NDABioMarin Pharmaceutical Inc.68135-300-02120 TABLET in 1 BOTTLE (68135-300-02)
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