For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive…. ANDA 207207, held by Ph Health. Sapropterin Dihydrochloride.
As of Nov 15, 2026, ANDA 207207 (Sapropterin Dihydrochloride), held by Ph Health, was first approved by FDA on Aug 20, 2019, with 2 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sapropterin Dihydrochloride100MG/PACKET · for solution;oral | Sapropterin Dihydrochloride | Rx |
| Sep 9, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 9, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 20, 2019 | Original application | Approved |
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
