Sapropterin Dihydrochloride

For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive…. ANDA 215534, held by Annora Pharma. Sapropterin Dihydrochloride.

As of Nov 15, 2026, ANDA 215534 (Sapropterin Dihydrochloride), held by Annora Pharma, was first approved by FDA on Aug 23, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 23, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (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.

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
Aug 23, 2022	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Apr 3, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Aug 23, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 215534
Drugs@FDA: Overview at FDA
Company: Annora Pharma

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