Sapropterin Dihydrochloride

For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive…. ANDA 215420, held by Annora Pharma. Sapropterin Dihydrochloride.

As of Nov 15, 2026, ANDA 215420 (Sapropterin Dihydrochloride), held by Annora Pharma, was first approved by FDA on Aug 18, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 18, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sapropterin dihydrochloride powder for oral solution is 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 powder for oral solution is 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 18, 2022	Original application	Approved	None posted

Products

2 strengths and forms


Sapropterin Dihydrochloride100MG/PACKET · for solution;oral	Sapropterin Dihydrochloride	Rx
Sapropterin Dihydrochloride500MG/PACKET · for solution;oral	Sapropterin Dihydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Jan 24, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Aug 18, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 215420
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