Sapropterin Dihydrochloride

For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive…. ANDA 215798, held by Dr Reddys. Sapropterin Dihydrochloride.

As of Nov 15, 2026, ANDA 215798 (Sapropterin Dihydrochloride), held by Dr Reddys, was first approved by FDA on May 13, 2022, with 3 approved supplements and 0 published complete response letters.

First approved: May 13, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JAVYGTOR 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). JAVYGTOR 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 4 submissions below

Date	Submission	Status	Documents
May 13, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sapropterin Dihydrochloride500MG/PACKET · for solution;oral	Sapropterin Dihydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Jan 24, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Mar 15, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Sep 26, 2022	Supplement 1Labeling · Standard review	Approved	None posted
May 13, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 215798
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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