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Sapropterin Dihydrochloride

These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS and SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS and SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION.SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007

Approved
Approval ID

83bf50fd-f70c-037a-5c8f-b32f69208d20

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2021

Manufacturers
FDA

Dr. Reddys Laboratories Inc.

DUNS: 802315887

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sapropterin Dihydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-749
Application NumberNDA022181
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sapropterin Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2021
FDA Product Classification

INGREDIENTS (1)

SAPROPTERIN DIHYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: RG277LF5B3
Classification: ACTIB

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Sapropterin Dihydrochloride - FDA Drug Approval Details