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Medicines · US (FDA)

FDA 2022

FDA

Sapropterin Dihydrochloride

Approved 13 May 2022OralPowder

The FDA lists this product in 15 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA207207-001 · Prescription
SAPROPTERIN DIHYDROCHLORIDE 100MG · TabletANDA215534-001 · Prescription
SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderANDA216432-002 · Prescription
SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA216432-001 · Prescription
SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA219511-001 · Prescription
SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderANDA219511-002 · Prescription
SAPROPTERIN DIHYDROCHLORIDE 100MG · TabletANDA218797-001 · Prescription
SAPROPTERIN DIHYDROCHLORIDE 100MG · TabletANDA207200-001 · Prescription
SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA209452-001 · Prescription

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA215420-001 · Prescription

SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderANDA215420-002 · Prescription

SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderThis page

SAPROPTERIN DIHYDROCHLORIDE 100MG · TabletANDA207685-001 · Prescription

SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderANDA210027-001 · Prescription

SAPROPTERIN DIHYDROCHLORIDE 100MG · TabletANDA216797-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA215798.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Sapropterin Dihydrochloride
Route: Oral
Dosage form: Powder
Applicant: DR Reddys
Status: Prescription
FDA approval: 13 May 2022
Application: ANDA215798-001