Agamree Kit
Product Images NDC 69616-264

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Agamree (NDC 69616-264). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Catalyst Pharmaceuticals, 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

Structural Formula (Aga01 0008 01)

Chemical structure diagram of vamorolone, the active ingredient in AGAMREE. The structure shows the steroid backbone with specific stereochemistry and functional groups including hydroxyl and ketone groups.*

FDA Label Image

Figure 1 (Aga01 0008 02)

A line graph showing mean (SEM) change from baseline over 24 weeks for three groups: Placebo, AGAMREE 2.0 mg/kg, and AGAMREE 6.0 mg/kg. The x-axis represents time in weeks (0, 6, 12, 24), and the y-axis shows mean change from baseline. Both AGAMREE doses show an increasing trend compared to placebo over time.*

FDA Label Image

Figure (Aga01 0008 03)

An instructional diagram showing the components of the AGAMREE oral suspension kit by Catalyst Pharmaceuticals, Inc. It highlights a bottle with a child-resistant cap, prescribing information leaflet, and an oral syringe with labeled parts: barrel, tip, plunger, and bottle adapter, used for oral administration.*

FDA Label Image

Figure (Aga01 0008 04)

An instructional illustration showing a hand holding and shaking an oral medication bottle vertically, indicating the need to mix the contents before use. The bottle has a grip cap to facilitate shaking.*

FDA Label Image

Figure (Aga01 0008 05)

Instructional illustration showing hands holding an oral medication bottle labeled as AGAMREE (vamorolone). The image demonstrates removing or adjusting the cap, indicating steps for opening the bottle.*

FDA Label Image

Figure (Aga01 0008 06)

An instructional illustration showing a pair of hands holding a bottle and an applicator tip. The illustration demonstrates the action of attaching or removing the applicator tip from the bottle, likely related to preparing the oral medication kit AGAMREE (Vamorolone) by Catalyst Pharmaceuticals, Inc.*

FDA Label Image

Figure (Aga01 0008 07)

Illustration showing a close-up of a measuring device or syringe positioned above a container opening, with an arrow pointing towards the container, indicating a direction for filling or inserting the device. No text or branding is visible.*

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Figure (Aga01 0008 08)

An instructional illustration showing a hand holding a syringe-like device with an arrow indicating a downward motion. This image appears to demonstrate how to properly hold and position the oral medication delivery kit, AGAMREE (vamorolone).*

FDA Label Image

Figure (Aga01 0008 09)

An instructional diagram showing a hand holding a dropper bottle with a liquid inside. The image illustrates the step of pressing down on the dropper inside the bottle cap to extract the liquid, likely part of the liquid dose measurement or administration process for AGAMREE oral kit by Catalyst Pharmaceuticals, Inc.*

FDA Label Image

Figure (Aga01 0008 10)

An instructional illustration showing hands drawing liquid medication from a bottle into a graduated syringe, indicating the process of preparing an oral dose. The syringe has measurement markings, and an arrow points downward to suggest pulling the plunger.*

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Figure (Aga01 0008 11)

An instructional diagram showing proper and improper techniques for transferring liquid from a bottle to a syringe. The correct method involves holding the bottle upright while drawing liquid into the syringe, while an incorrect method shows the bottle tilted, which is not recommended.*

FDA Label Image

Figure (Aga01 0008 12)

An instructional illustration showing a hand holding a bottle while another hand turns a syringe or dropper into the bottle's opening with a clockwise arrow indicating the direction to turn. This image likely demonstrates how to prepare or use the medication kit AGAMREE containing vamorolone for oral administration.*

FDA Label Image

Figure (Aga01 0008 13)

An instructional diagram showing a person holding an oral medication dispenser, with an arrow indicating the direction to administer the dose into the mouth. The image relates to the AGAMREE (Vamorolone) oral kit by Catalyst Pharmaceuticals, Inc., demonstrating proper use of the dosing device.*

FDA Label Image

Figure (Aga01 0008 14)

An instructional illustration showing hands holding and twisting the cap of an oral medication bottle, demonstrating the opening or closing action. The image is likely part of a user guide for the AGAMREE VAMOROLONE oral kit by Catalyst Pharmaceuticals, Inc.*

FDA Label Image

Figure (Aga01 0008 15)

An instructional illustration showing two steps involving water and a tube for oral administration. On the left, a hand holds an upright tube beneath a faucet, indicating water is being poured into the tube. On the right, a hand uses a spoon to mix or stir the contents inside the tube. Below these images, two closed tubes are shown horizontally.*

FDA Label Image

Label-01 (Aga01 0008 16)

Packaging label for AGAMREE (vamorolone) oral suspension 40 mg/mL by Catalyst Pharmaceuticals, Inc. The carton is designed for a 100 mL bottle and includes dosing and storage instructions, prescription-only labeling, and comes with oral syringes and a press-in-bottle adapter. The label also contains barcode and regulatory information.*

FDA Label Image

Label-02 (Aga01 0008 17)

Label for AGAMREE oral suspension, 40 mg/mL (vamorolone) by Catalyst Pharmaceuticals, Inc. The label specifies it is an oral suspension for prescription use only with a 100 mL container. It includes storage instructions, dosage reference to prescribing information, and a note to discard unused suspension after 3 months of first opening. Manufactured in Italy, with an NDC of 69616-265-38.*

* 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.