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Data / Drug companies / Phenylalanine Hydroxylase Activator

Phenylalanine Hydroxylase Activator drugs: 1 drug from 10 companies in the FDA NDC directory

Phenylalanine Hydroxylase Activator is an FDA established pharmacologic class. The FDA National Drug Code Directory lists 23 products in this class from 10 companies, covering 1 drug by generic name. The main marketing category is generic drugs (ANDA), and the newest product started marketing on April 1, 2026.

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  • 10Companies
  • 23Products
  • 1Drugs by generic name

Drugs in the Phenylalanine Hydroxylase Activator class

Ranked by number of companies that list the drug.

DrugProducts hereCompanies listing it
Sapropterin dihydrochloride2310

Companies with the most products in this class

CompanyProductsMain dosage formsMain marketing categoryNewest product started
BioMarin Pharmaceutical Inc.3powder, for solution; tabletNew drug applications (NDA)May 27, 2015
Camber Pharmaceuticals, Inc.3powder, for solution; tabletGeneric drugs (ANDA)August 23, 2022
Dr. Reddy's Laboratories Inc.3powder, for solution; tabletGeneric drugs (ANDA)November 16, 2022
NorthStar RxLLC3powder, for solution; tabletGeneric drugs (ANDA)December 1, 2023
Par Health USA, LLC3powder, for solution; tabletGeneric drugs (ANDA)October 1, 2020
Aucta Pharmaceuticals, Inc.2powder, for solutionGeneric drugs (ANDA)April 29, 2025
Micro Labs Limited2powder, for solutionGeneric drugs (ANDA)April 1, 2026
TruPharma, LLC2powder, for solutionGeneric drugs (ANDA)January 30, 2026
Aurobindo Pharma Limited1tabletGeneric drugs (ANDA)June 9, 2025
Hikma Pharmaceuticals USA Inc.1tabletGeneric drugs (ANDA)October 23, 2025

Dosage forms

Dosage formProductsShare
Powder, for solution1669.6%
Tablet730.4%

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.