Imkeldi Solution
Product Images NDC 81927-201

Product Visual Gallery

This gallery contains 27 technical images submitted to the FDA as part of the official labeling for Imkeldi (NDC 81927-201). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Shorla Oncology 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

Carton (Carton)

Packaging label for Imkeldi (imatinib) Oral Solution 80 mg/mL by Shorla Oncology Inc. The label includes warnings for use as a hazardous drug, instructions for oral use only, dosage information, storage conditions, and manufacturer details. The package volume indicated is 140 mL, with barcodes present on the label.*

FDA Label Image

Figure A (Figure A)

An instructional diagram showing components related to administration of IMKELDI oral solution. It depicts an oral dispensing syringe labeled with tip, barrel, and plunger (not included), a bottle of the solution, a bottle adapter (not included), and disposable gloves (not included). These items illustrate tools needed for proper dosing and handling.*

FDA Label Image

Figure B (Figure B)

An instructional illustration showing two hands being washed under a running faucet with soap bubbles, demonstrating proper handwashing technique.*

FDA Label Image

Figure C (Figure C)

An instructional illustration showing two hands demonstrating the proper technique to twist open a child-resistant bottle cap. One hand grips the bottle while the other twists the cap counterclockwise, indicated by a curved arrow.*

FDA Label Image

Figure D (Figure D)

An instructional illustration showing two hands removing a cap from a small bottle, with an arrow pointing downward toward the bottle's opening. The image suggests a step in preparing the oral solution for use.*

FDA Label Image

Figure E (Figure E)

An instructional illustration showing two hands opening a bottle. One hand grips the bottle while the other hand twists the cap counterclockwise, indicating the method to open the container.*

FDA Label Image

Figure F (Figure F)

A black and white instructional illustration showing two hands handling an oral syringe, likely demonstrating proper technique for measuring or administering a liquid medication dose.*

FDA Label Image

Figure G (Figure G)

An instructional illustration showing a person using a dropper or syringe to withdraw liquid medication from a bottle. The image depicts hand placement on the bottle and dropper, with an arrow indicating the direction of insertion of the dropper into the bottle opening.*

FDA Label Image

Figure H (Figure H)

An instructional illustration showing a person using both hands to prepare an oral solution medication with a syringe, indicating the method to draw the liquid from a bottle or vial.*

FDA Label Image

Figure I (Figure I)

An instructional illustration showing a hand holding a vial and drawing liquid medication into a syringe, demonstrating the preparation of a dose of oral solution.*

FDA Label Image

Figure J (Figure J)

An instructional black and white line drawing showing a hand holding a bottle upside down and another hand holding a syringe below it, as if drawing liquid from the bottle into the syringe. The image suggests steps for extracting medication from a bottle using a syringe and needle.*

FDA Label Image

Figure K (Figure K)

An instructional illustration showing a hand holding a bottle upside down while another hand holds a syringe positioned below the bottle opening, demonstrating how to draw liquid from the bottle using the syringe.*

FDA Label Image

Figure L (Figure L)

An instructional illustration showing a hand with a glove removing liquid from a bottle using a syringe. The bottle is small with a blank label, indicating preparation or dosing of an oral solution.*

FDA Label Image

Figure M (Figure M)

Illustration showing two gloved hands, one holding a bottle upright and the other inserting a syringe into the bottle's opening, demonstrating the proper technique for withdrawing liquid from the bottle.*

FDA Label Image

Figure N (Figure N)

An instructional illustration showing a pair of gloved hands holding an oral drug syringe filled with medication, typically used for measuring and administering liquid oral medications like IMKELDI (imatinib oral solution). The syringe is held upright, demonstrating proper handling technique.*

FDA Label Image

Figure O (Figure O)

An instructional illustration showing a person swallowing oral solution medication from a syringe, demonstrating the proper method for taking the solution by mouth.*

FDA Label Image

Figure P (Figure P)

An instructional diagram showing the proper method of administering oral liquid medication using a syringe placed inside a patient's mouth.*

FDA Label Image

Figure Q (Figure Q)

FDA Label Image

Figure R (Figure R)

An instructional illustration showing two hands demonstrating how to twist open a bottle cap, likely indicating the proper method to open the medication bottle for oral solution use.*

FDA Label Image

Figure S (Figure S)

Illustration showing hands wearing gloves holding a graduated measuring container under a faucet with water and soap suds, suggesting proper handwashing technique or hygiene practice.*

FDA Label Image

Figure (Figure1)

A line graph depicting the percentage of patients without progression over 72 months since randomization, comparing two treatment groups: Gleevec® arm and IFN+Ara-C arm. The graph includes survival curves, numbers of patients at various stages, hazard ratio with confidence interval, and a log-rank test p-value indicating statistical significance.*

FDA Label Image

Figure (Figure2)

A Kaplan-Meier survival curve chart comparing the percentage of patients without progression to AP/BC over 72 months since randomization between two treatment arms: Gleevec® and IFN+Ara-C. The chart includes patient numbers, hazard ratio, confidence intervals, and a log-rank test P-value.*

FDA Label Image

Figure (Figure3)

A survival plot graph showing the probability of being alive and recurrence-free over time (in months) for two groups: one receiving 400 mg imatinib and the other placebo. The graph includes censored data points and a table below indicating patient numbers at risk at various time intervals up to 108 months.*

FDA Label Image

Figure (Figure4)

A Kaplan-Meier survival curve chart depicting the probability of recurrence-free survival over time in months for two groups treated with imatinib oral solution. It compares 12 months versus 36 months of treatment, showing survival probabilities along the y-axis and time (in months) along the x-axis, including at-risk and event counts below the graph.*

FDA Label Image

Figure (Figure5)

A survival curve graph showing the probability of overall survival over time in months. The graph compares two groups labeled as Imatinib 12 MO and Imatinib 36 MO, with censored observations indicated. The y-axis represents probability of overall survival, and the x-axis denotes survival time in months, with event counts and numbers at risk detailed below the graph.*

FDA Label Image

Label (Label)

Label for IMKELDI (imatinib oral solution) 80 mg/mL, a prescription oral solution by Shorla Oncology Inc. The 140 mL bottle label includes dosage strength, usage warnings, storage instructions, and a batch number and expiration date area. It instructs oral use only and notes the product is a hazardous drug.*

FDA Label Image

Structure (Structure1)

Chemical structure diagram of imatinib, the active ingredient in IMKELDI oral solution 80 mg/mL by Shorla Oncology Inc. The structure includes multiple aromatic rings, nitrogen-containing heterocycles, and functional groups representing the compound's molecular arrangement.*

* 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.