Javygtor Powder, For Solution
Product Images NDC 43598-097

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Javygtor (NDC 43598-097). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr. Reddys Laboratories Inc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure1 (Figure1)

A line graph showing Blood Phe (phenylalanine) Level (µmol/L) over study visits from Baseline to Month 6. Two age groups are compared: 1 month to <2 years (solid line) and 2 to <7 years (dashed line). The graph includes error bars representing 95% confidence intervals and a dotted horizontal line indicating the Target Blood Phe Control Range. Blood Phe levels decrease sharply after Baseline and then gradually increase over time for both groups.*

FDA Label Image

Carton (Carton)

JAVYGTOR 100 mg powder for oral solution carton label showing product name, generic name sapropterin dihydrochloride, quantity of 30 individual packets per carton, and manufacturer Dr. Reddy's Laboratories Inc. The label includes storage instructions, dosage form, NDC 43598-097-30, and distributor information from Dr. Reddy's Laboratories in Princeton, NJ.*

FDA Label Image

Figure2 (Figure2)

A line graph comparing blood PK (pharmacokinetic) levels in micromoles per liter over study visits from week -2 to week 6 for Sapropterin Dihydrochloride and placebo groups. The graph includes error bars indicating 95% confidence intervals and shows a significant difference with p < 0.001.*

FDA Label Image

Figurea (Figurea)

An instructional illustration showing an oral dosing syringe labeled with parts: barrel, tip, and plunger. Below are two cups labeled 'medicine cup' and 'water or apple juice cup,' indicating recommended liquids for use with the syringe. This diagram is likely intended to guide proper administration of a medication solution.*

FDA Label Image

Figureb (Figureb)

An instructional diagram showing powder being poured into a medicine cup filled to the indicated liquid line. The cup is labeled and used for preparing a solution form of the medication.*

FDA Label Image

Figurec (Figurec)

An instructional illustration showing a hand pouring JAVYGTOR (Sapropterin Dihydrochloride) powder from a packet into a medicine cup for oral administration. The image is labeled as Figure C and includes the text 'medicine cup.'*

FDA Label Image

Figured (Figured)

An instructional illustration labeled 'Figure D' showing a hand stirring a medicine cup with a stirring stick or similar tool.*

FDA Label Image

Figuree (Figuree)

Illustration showing a hand dispensing a powdered substance from a container into a medicine cup, depicting the preparation step for a powder for solution oral dosage form.*

FDA Label Image

Figuref (Figuref)

An instructional diagram showing a hand holding a syringe with labeled parts including the tip and the liquid line. It appears to demonstrate measuring or drawing liquid, likely related to the preparation or administration of the oral powder solution for Sapropterin Dihydrochloride (JAVYGTOR).*

FDA Label Image

Figureg (Figureg)

An instructional illustration showing a person administering an oral solution using a syringe to a child's mouth. The image depicts the correct positioning and method for oral dosing with a syringe.*

FDA Label Image

Sachet (Sachet)

JAVYGTOR 100 mg powder for oral solution packaging label featuring sapropterin dihydrochloride as the active ingredient. The label includes directions for opening, the NDC 43598-097-11, and prescribing information such as Rx only. The labeler is Dr. Reddys Laboratories Inc. The design shows the product name prominently with a distinctive orange arc element on a white background.*

FDA Label Image

Structure (Structure)

Chemical structure of Sapropterin Dihydrochloride, the active ingredient in JAVYGTOR 100 mg oral powder for solution. The diagram shows the molecular structure with detailed atom and bond arrangements, including the dihydrochloride component (2 HCl).*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.