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 0000 01)

Chemical structure of vamorolone, displayed as a skeletal formula highlighting stereochemistry, hydroxyl groups, and ketone functionalities.*

FDA Label Image

Figure 1 (Aga01 0000 02)

A line chart depicting mean (SEM) change from baseline over 24 weeks for placebo, AGAMREE 2.0 mg/kg, and AGAMREE 6.0 mg/kg groups. The x-axis represents weeks (0, 6, 12, 24) and the y-axis shows mean change values. Data trends illustrate increasing changes over time for the AGAMREE dosage groups compared to placebo.*

FDA Label Image

Figure (Aga01 0000 03)

An instructional diagram showing components of the AGAMREE oral suspension kit, including a child-resistant cap bottle with a label, prescribing information with instructions for use, and an oral syringe with identified parts: plunger, barrel, tip, and bottle adapter.*

FDA Label Image

Figure (Aga01 0000 04)

An instructional illustration showing a hand holding a small bottle with a screw cap, demonstrating the motion to shake the bottle up and down. This likely indicates preparation instructions for an oral liquid dosage form in the AGAMREE (Vamorolone) oral kit by Catalyst Pharmaceuticals, Inc.*

FDA Label Image

Figure (Aga01 0000 05)

Illustration showing hands opening an oral medication bottle by pressing down and turning the cap, demonstrating the child-resistant safety feature commonly found on prescription drug bottles.*

FDA Label Image

Figure (Aga01 0000 06)

An instructional illustration showing hands holding an oral medication bottle with a dropper-like cap. It depicts the action of pressing or squeezing the top of the cap, likely demonstrating how to open or operate the bottle dispensing mechanism.*

FDA Label Image

Figure (Aga01 0000 07)

An instructional diagram showing a close-up of a syringe inserted into a container with a plunger, alongside an arrow indicating a direction or motion, likely depicting a step in the preparation or administration process for the AGAMREE oral kit.*

FDA Label Image

Figure (Aga01 0000 08)

An instructional illustration showing a hand holding a syringe with the thumb pressing down on the plunger, accompanied by a downward arrow indicating the direction to push the plunger.*

FDA Label Image

Figure (Aga01 0000 09)

An instructional illustration showing a hand holding a vial while a syringe needle is inserted into its stopper, demonstrating the step of drawing liquid from the vial for oral administration in the AGAMREE kit.*

FDA Label Image

Figure (Aga01 0000 10)

An instructional illustration showing hands dispensing a liquid medication from a bottle into an oral syringe, demonstrating how to measure the dosage accurately, associated with an oral medication kit.*

FDA Label Image

Figure (Aga01 0000 11)

Illustration showing proper technique for preparing a liquid dose from a bottle using a syringe. The correct method involves holding the bottle upright to draw liquid into the syringe, while an incorrect method shows the bottle upside down.*

FDA Label Image

Figure (Aga01 0000 12)

Illustration showing how to prepare an oral liquid medication using a syringe and a bottle. One hand holds the bottle steady while the other hand turns the syringe to draw the medication, demonstrating the correct method for withdrawing the dose.*

FDA Label Image

Figure (Aga01 0000 13)

An instructional illustration showing a person using an oral device. The person is opening their mouth while another hand holds the device, guiding it toward the mouth with an arrow indicating the direction of insertion.*

FDA Label Image

Figure (Aga01 0000 14)

An instructional diagram showing a hand twisting the cap of a bottle, indicating how to open the container. The illustration is part of a guide for the AGAMREE (vamorolone) oral kit by Catalyst Pharmaceuticals, Inc.*

FDA Label Image

Figure (Aga01 0000 15)

An instructional illustration showing two faucets labeled for handwashing on either side of a person holding a swab and container, with two swabs and containers on a tray below. The image likely demonstrates a procedure for sample collection or cleaning using two separate stations.*

FDA Label Image

Principal Display Panel – 100 mL Carton Label (Aga01 0000 16)

Packaging label for AGAMREE (vamorolone) oral suspension kit containing 40 mg/mL concentration. The carton states the content is for oral administration only, with a volume of 100 mL. The labeler is Catalyst Pharmaceuticals, Inc., and the product is prescription-only. The kit includes a 25 mL bottle, two 5 mL oral syringes, a press-in-bottle adapter, and prescribing information.*

FDA Label Image

Principal Display Panel – 100 mL Carton Label (Aga01 0000 17)

Label for AGAMREE (vamorolone) oral suspension with a strength of 40 mg/mL in a 100 mL bottle. The label indicates the product is for oral use only, prescription only, and provides storage instructions to keep at room temperature between 68°F to 77°F and to refrigerate after opening. The label also notes that unused suspension should be discarded after 3 months. Manufactured for Catalyst Pharmaceuticals, Inc., Coral Gables, FL, and made in Italy.*

* 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.