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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216432


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NDA 216432 describes SAPROPTERIN DIHYDROCHLORIDE, which is a drug marketed by Annora Pharma, Dr Reddys, Hopewell Pharma, Ph Health, Aurobindo Pharma, and Zenara, and is included in eleven NDAs. It is available from seven suppliers. Additional details are available on the SAPROPTERIN DIHYDROCHLORIDE profile page.

The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 216432
Tradename:SAPROPTERIN DIHYDROCHLORIDE
Applicant:Hopewell Pharma
Ingredient:sapropterin dihydrochloride
Patents:0
Pharmacology for NDA: 216432
Mechanism of ActionBreast Cancer Resistance Protein Inhibitors
P-Glycoprotein Inhibitors
Phenylalanine Hydroxylase Activators
Suppliers and Packaging for NDA: 216432
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 216432 ANDA TRUPHARMA, LLC 52817-850 52817-850-01 1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01)
SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 216432 ANDA TRUPHARMA, LLC 52817-850 52817-850-30 30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength100MG/PACKET
Approval Date:Sep 3, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength500MG/PACKET
Approval Date:Sep 3, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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