Sapropterin Dihydrochloride

For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive…. ANDA 207200, held by Ph Health. Sapropterin Dihydrochloride.

As of Nov 15, 2026, ANDA 207200 (Sapropterin Dihydrochloride), held by Ph Health, was first approved by FDA on May 10, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: May 10, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe-restricted diet. Sapropterin dihydrochloride tablets are a phenylalanine hydroxylase activator

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 10, 2019	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sapropterin Dihydrochloride100MG · tablet;oral	Sapropterin Dihydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Sep 9, 2020	Supplement 2Labeling · Standard review	Approved	None posted
May 10, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 207200
Drugs@FDA: Overview at FDA
Company: PH Health

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters