Last Updated: May 14, 2026

Details for New Drug Application (NDA): 219511


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NDA 219511 describes SAPROPTERIN DIHYDROCHLORIDE, which is a drug marketed by Annora Pharma, Dr Reddys, Micro Labs, Ph Health, Tp Anda Holdings, Aurobindo Pharma, and Zenara, and is included in twelve NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 219511
Tradename:SAPROPTERIN DIHYDROCHLORIDE
Applicant:Micro Labs
Ingredient:sapropterin dihydrochloride
Patents:0
Pharmacology for NDA: 219511
Mechanism of ActionBreast Cancer Resistance Protein Inhibitors
P-Glycoprotein Inhibitors
Phenylalanine Hydroxylase Activators
Suppliers and Packaging for NDA: 219511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 219511 ANDA Micro Labs Limited 42571-509 42571-509-41 30 PACKET in 1 CARTON (42571-509-41) / 1 POWDER, FOR SOLUTION in 1 PACKET (42571-509-30)
SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 219511 ANDA Micro Labs Limited 42571-510 42571-510-41 30 PACKET in 1 CARTON (42571-510-41) / 1 POWDER, FOR SOLUTION in 1 PACKET (42571-510-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength100MG/PACKET
Approval Date:Jan 8, 2026TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength500MG/PACKET
Approval Date:Jan 8, 2026TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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