Sildenafil For Suspension
Product Images NDC 70954-168

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 70954-168). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ani 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.

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Figure A (Fig Ifu A)

An instructional diagram showing labeled parts of an oral suspension medication package and syringe. Labels identify the bottle with suspension, cap, and syringe adaptor, alongside a syringe with labeled tip, barrel, and plunger, illustrating components used for measuring and administering the liquid dose.*

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Figure B (Fig Ifu B)

Instructional illustration showing proper handling of a prescription suspension bottle, including shaking the bottle, timing with a stopwatch, and manipulating the cap to open or close. The image demonstrates steps for preparing an oral suspension medication for use.*

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Figure C (Fig Ifu C)

An instructional illustration showing how to insert a dosing syringe into the neck of an oral suspension bottle, indicating the proper technique for drawing the liquid medication from the bottle.*

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Figure D (Fig Ifu D)

An instructional illustration showing how to draw liquid medication from a bottle into a syringe. The bottle is held upside down with the syringe inserted in the opening. Volume markings on the syringe read 0.5 mL and 2 mL. A downward arrow indicates the plunger being pressed.*

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Figure E (Fig Ifu E)

An instructional illustration showing a syringe being withdrawn vertically from a bottle containing a liquid suspension. The image likely demonstrates a step in the preparation or administration of an oral suspension medication.*

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Figure F (Fig Ifu F)

An instructional illustration showing administration of an oral suspension using a syringe. The syringe is positioned at the mouth, with liquid being dispensed onto or into the lips, suggesting proper use for oral dosing of medication suspensions.*

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Figure G (Fig Ifu G)

An instructional black-and-white line illustration showing a water faucet with liquid being poured into two oral syringes labeled with measurement markings of 0.5 mL, 1 mL, and 2 mL. This diagram appears to demonstrate dilution or preparation of oral suspension doses using water and syringes.*

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Figure3 (Figure 1)

An instructional illustration showing a bottle containing suspension liquid and a single oral syringe with volume markings. The image likely demonstrates the use of the syringe to measure and administer a liquid medication dose.*

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Figure1 (Figure 201)

An instructional diagram showing a graduated cylinder on the left, a medicine bottle filled partially with liquid in the center, and a dosing syringe marked with graduated measurements on the right. The syringe image is marked with "x1" indicating one unit dose, illustrating proper measurement and administration of an oral suspension medication.*

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Figure7 (Figure7)

A forest plot depicting drug interaction effects on Sildenafil pharmacokinetics, showing fold change and 90% confidence intervals for AUC and Cmax of various interacting drugs relative to Sildenafil alone. Recommendations for dose adjustment accompany each interaction, with most advising no dose adjustment except for Ritonavir, which is not recommended for coadministration.*

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Figure8 (Figure8)

A chart showing fold change and 90% confidence intervals for sildenafil pharmacokinetics or pharmacodynamics when coadministered with various interacting drugs. The x-axis depicts change relative to the interacting drug alone. The chart includes drugs like Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin, Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide, with recommendations for dose adjustment or coadministration noted.*

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Figure_10 (Figure 10)

A forest plot chart showing placebo-corrected change in 6-minute walk distance (in meters) for Sildenafil 20 mg TID across various baseline characteristics such as baseline walk distance, etiology, functional capacity class, gender, age, mean PAP, and PVRI. The plot includes patient counts for placebo and Sildenafil groups and error bars indicating variability in each subgroup.*

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Figure_11 (Figure 11)

A line graph comparing the percentage of subjects without a clinically worsening event over time between placebo and sildenafil groups. The x-axis represents days from randomization (0 to 112 days), and the y-axis shows the percentage without worsening events. Sildenafil group shows a higher percentage consistently than placebo over the study period.*

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Figure_12 (Figure 12)

A line plot chart showing the mean change from baseline (in meters) over 12 weeks of study for Sildenafil oral suspension at doses 1 mg TID, 5 mg TID, and 20 mg TID. The vertical axis shows change from baseline, while the horizontal axis shows weeks 4, 8, and 12. Error bars indicate the standard error for each dose group at each time point.*

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Figure_2 (Figure 2)

An instructional diagram showing how to prepare sildenafil citrate oral suspension. It depicts three steps: pressing and twisting the bottle cap to open, shaking the bottle up and down to mix the contents, and timing 20 seconds with a stopwatch to ensure thorough mixing before use.*

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Figure_5 (Figure 5)

An instructional illustration showing how to open a bottle for an oral suspension medication. The first step depicts pressing down on the childproof cap before removing it. The second step shows twisting the cap counterclockwise to open the bottle.*

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Figure_6 (Figure 6)

A Kaplan-Meier survival curve graph showing estimated cumulative mortality rate (%) over time in years. The graph compares three groups labeled High Dose, Medium Dose, and Low Dose, with High Dose showing the highest mortality rate increase, Medium Dose intermediate, and Low Dose the lowest. Numbers at risk for each group are displayed above the graph at multiple time points.*

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Figure_9 (Figure 9)

A line graph showing change from baseline in meters over study weeks 4, 8, and 12 for different Sildenafil dosages (40 mg TID, 20 mg TID, 80 mg TID) and placebo. The vertical axis represents change from baseline in meters, the horizontal axis shows weeks of study, and error bars indicate variability for each data point.*

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Structure (Structure)

Chemical structure of sildenafil citrate, the active ingredient in Sildenafil oral suspension 10 mg/mL by ANI Pharmaceuticals, Inc. The diagram shows the molecular arrangement of atoms and bonds specific to sildenafil citrate.*

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Newcarton

This is the packaging label for Sildenafil for Oral Suspension, 10 mg/mL, by Novitium Pharma. It is a 112 mL grape-flavored oral suspension for prescription use only. The label includes storage and reconstitution instructions, dosage information, and manufacturer details from Novitium Pharma LLC in East Windsor, New Jersey.*

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Newcontainer

Label for Sildenafil for Oral Suspension 10 mg/mL, a prescription oral suspension. The label includes storage instructions before and after reconstitution, dosage information stating each mL contains 10 mg of sildenafil citrate when reconstituted with 90 mL water, and a total bottle content of 112 mL. It specifies the product is grape flavored, manufactured by Novitium Pharma LLC, East Windsor, New Jersey. It also includes a barcode and notes to shake well before use.*

* 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.