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.
| Drug | Products here | Companies listing it |
|---|---|---|
| Sapropterin dihydrochloride | 23 | 10 |
Companies with the most products in this class
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| BioMarin Pharmaceutical Inc. | 3 | powder, for solution; tablet | New drug applications (NDA) | May 27, 2015 |
| Camber Pharmaceuticals, Inc. | 3 | powder, for solution; tablet | Generic drugs (ANDA) | August 23, 2022 |
| Dr. Reddy's Laboratories Inc. | 3 | powder, for solution; tablet | Generic drugs (ANDA) | November 16, 2022 |
| NorthStar RxLLC | 3 | powder, for solution; tablet | Generic drugs (ANDA) | December 1, 2023 |
| Par Health USA, LLC | 3 | powder, for solution; tablet | Generic drugs (ANDA) | October 1, 2020 |
| Aucta Pharmaceuticals, Inc. | 2 | powder, for solution | Generic drugs (ANDA) | April 29, 2025 |
| Micro Labs Limited | 2 | powder, for solution | Generic drugs (ANDA) | April 1, 2026 |
| TruPharma, LLC | 2 | powder, for solution | Generic drugs (ANDA) | January 30, 2026 |
| Aurobindo Pharma Limited | 1 | tablet | Generic drugs (ANDA) | June 9, 2025 |
| Hikma Pharmaceuticals USA Inc. | 1 | tablet | Generic drugs (ANDA) | October 23, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Powder, for solution | 16 | 69.6% |
| Tablet | 7 | 30.4% |
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.