sapropterin dihydrochloride
sapropterin dihydrochloride is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including sapropterin dihydrochloride, Kuvan, ZELVYSIA. Available dosage forms: tablet, powder, for solution.
Drug Details
- Generic Name
- sapropterin dihydrochloride
- Brand Names
- sapropterin dihydrochloride, Kuvan, ZELVYSIA
- Application Number
- ANDA215534
- Sponsor
- Camber Pharmaceuticals, Inc.
- NDC Codes
- 6
- Dosage Forms
- TABLET, POWDER, FOR SOLUTION
- Routes
- ORAL
- Active Ingredients
- SAPROPTERIN DIHYDROCHLORIDE
Indications and Usage
1 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. Sapropterin dihydrochloride powder for oral solution is a phenylalanine hydroxylase activator 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. ( 1 )