Sildenafil For Oral Suspension
Product Images NDC 72205-035

22 FDA label images from Novadoz Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Sildenafil For Oral Suspension (NDC 72205-035). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novadoz Pharmaceuticals Llc, 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

Figure 1 (Revatio 01)

Figure 1 (Revatio 01)
An instructional illustration showing a graduated cylinder, a bottle half-filled with liquid, and a syringe with measurement markings labeled 'x 1'. The image appears to demonstrate measurement or dosing steps for a liquid medication.*
FDA Label Image

Figure 2 (Revatio 02)

Figure 2 (Revatio 02)
Instructional illustration showing how to prepare Sildenafil for Oral Suspension. It depicts pressing down and twisting the bottle cap to open, shaking the bottle up and down to mix the suspension, and using a timer to measure 30 seconds for shaking.*
FDA Label Image

Figure 3 (Revatio 03)

Figure 3 (Revatio 03)
An instructional illustration showing a bottle partially filled with liquid and two measuring devices: a graduated cylinder on the left and a syringe on the right marked with volume increments from 1 to 10 and labeled "x 1". The diagram likely demonstrates measuring or dosing the oral suspension.*
FDA Label Image

Figure 4 (Revatio 04)

Figure 4 (Revatio 04)
An instructional illustration showing how to prepare a suspension bottle. The steps include pressing down and twisting off the cap, shaking the bottle by moving it up and down with rotational motion, and then waiting for 30 seconds as indicated by a stopwatch graphic.*
FDA Label Image

Figure 5 (Revatio 05)

Figure 5 (Revatio 05)
An instructional illustration showing how to open and close a bottle with a child-resistant cap. The image demonstrates pressing down while turning the cap counterclockwise to open the bottle, and pressing down while turning the cap clockwise to close it.*
FDA Label Image

Figure 6 (Revatio 06)

Figure 6 (Revatio 06)
A Kaplan-Meier survival curve chart showing estimated cumulative mortality rates over a 5-year period for three dosage groups: High Dose, Medium Dose, and Low Dose. The y-axis represents mortality rate in percent and the x-axis represents time in years. The chart includes the number at risk for each group at various time points.*
FDA Label Image

Chemical Structure (Revatio 07)

Chemical Structure (Revatio 07)
Chemical structure of Sildenafil, the active ingredient in Sildenafil for Oral Suspension by Novadoz Pharmaceuticals LLC (NDC 72205-035). The diagram displays the molecular arrangement of atoms and bonds specific to Sildenafil.*
FDA Label Image

Figure 7 (Revatio 08)

Figure 7 (Revatio 08)
A horizontal error bar plot showing fold change and 90% confidence intervals for the area under the curve (AUC) and peak concentration (Cmax) of Sildenafil when coadministered with various interacting drugs, compared to Sildenafil alone (vertical solid line at x=1). The chart includes recommendations for dose adjustment, with most drugs indicating no dose adjustment, except for Ritonavir where coadministration is not recommended and Bosentan with a note of no benefit on exercise capacity.*
FDA Label Image

Figure 8 (Revatio 09)

Figure 8 (Revatio 09)
A chart showing fold change and 90% confidence intervals for various interacting drugs with sildenafil, accompanied by recommendations for dose adjustments. The x-axis indicates change relative to the interacting drug alone, ranging from 0.5 to 2. The chart includes drugs like Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin (three doses), Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide. Most interactions recommend no dose adjustment, except for Ritonavir, where coadministration is not recommended.*
FDA Label Image

Figure 9 (Revatio 10)

Figure 9 (Revatio 10)
A line graph depicting change from baseline (meters) over weeks 4, 8, and 12 of study. The x-axis shows the study weeks and the y-axis shows the change from baseline in meters, ranging from -20 to 80. Four groups are plotted with data points and error bars: Placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID, showing trends of increasing change over time for the Sildenafil doses compared to placebo.*
FDA Label Image

Figure 10 (Revatio 11)

Figure 10 (Revatio 11)
A horizontal forest plot comparing placebo-corrected changes in 6-minute walk distance among subgroups of patients treated with Sildenafil 20 mg TID. Subgroups include baseline walk distance, etiology of pulmonary arterial hypertension (PAH), functional class, gender, age, mean pulmonary artery pressure, and pulmonary vascular resistance index (PVRI). Each subgroup shows a point estimate with 95% confidence interval error bars.*
FDA Label Image

Figure 11 (Revatio 12)

Figure 11 (Revatio 12)
A Kaplan-Meier survival curve chart showing the percentage without a clinically worsening event over time in days from randomization. Two curves compare Placebo (solid line) and Sildenafil (dashed line), illustrating higher survival probability with Sildenafil throughout the 112-day period.*
FDA Label Image

Figure 12 (Revatio 13)

Figure 12 (Revatio 13)
A line plot showing the mean change from baseline in meters over 12 weeks for Sildenafil Oral Suspension at 1 mg, 5 mg, and 20 mg TID doses. The x-axis represents the week of study (Week 4, 8, 12) and the y-axis shows the change from baseline in meters. Error bars indicate standard error for each treatment dose at each time point.*
FDA Label Image

Figure A (Revatio 15)

Figure A (Revatio 15)
An illustration showing the components of a Sildenafil for Oral Suspension dosing system. It includes a bottle labeled 'REVATIO oral suspension' with a cap and syringe adaptor, alongside a dosing syringe featuring labeled parts: tip, barrel with volume markings (0.5 mL and 2 mL), and plunger.*
FDA Label Image

Figure B (Revatio 16)

Figure B (Revatio 16)
An instructional illustration showing three steps for handling a bottle of medication. The first image depicts shaking the bottle by moving it up and down and rotating it side to side. The second image shows a stopwatch or timer set at 5 seconds. The third image illustrates pressing down and twisting the bottle cap to open it. The visuals indicate proper preparation and opening of the suspension bottle.*
FDA Label Image

Figure C (Revatio 17)

Figure C (Revatio 17)
An instructional illustration showing a hand holding a bottle while using a syringe or dropper to withdraw liquid from the bottle. The syringe is inserted into the bottle opening, with an arrow indicating the downward motion to draw up the liquid.*
FDA Label Image

Figure D (Revatio 18)

Figure D (Revatio 18)
An instructional illustration showing a hand holding an upside-down bottle above a syringe to draw out liquid medication. The syringe has graduated markings at 0.5 mL and 2 mL for measuring the oral suspension dose.*
FDA Label Image

Figure E (Revatio 19)

Figure E (Revatio 19)
An instructional diagram showing a syringe being pulled up from a vial to extract liquid medication. The image is likely part of usage instructions for Sildenafil for Oral Suspension by Novadoz Pharmaceuticals LLC.*
FDA Label Image

Figure F (Revatio 20)

Figure F (Revatio 20)
An instructional line drawing showing a person administering oral medication using a syringe aimed at the mouth. The syringe is labeled with graduated markings and appears to be delivering a liquid dose into the oral cavity.*
FDA Label Image

Figure G (Revatio 21)

Figure G (Revatio 21)
An instructional illustration depicting a water faucet with liquid flowing into a container through two syringes. The syringes are marked with volume measurements, showing 0.5 mL and 2 mL. This image appears to demonstrate a method for measuring or mixing liquid medication.*
FDA Label Image

Principal Display Panel (10 mg/mL Bottle Label)

Principal Display Panel (10 mg/mL Bottle Label)
Label for Sildenafil for Oral Suspension 10 mg/mL by Novadoz Pharmaceuticals LLC. The label includes storage instructions before and after reconstitution, dosage form as oral suspension, total volume of 112 mL after reconstitution, and grape flavor. It also displays manufacturer and distributor information, NDC 72205-035-76, and notes to shake well before use.*
FDA Label Image

Principal Display Panel (10 mg/mL Bottle Carton)

Principal Display Panel (10 mg/mL Bottle Carton)
Sildenafil for Oral Suspension 10 mg/mL carton label with 112 mL volume and grape flavor, labeled for oral use only. The label includes reconstitution directions and storage instructions. Manufactured by AptaPharma Inc. and distributed by Novadoz Pharmaceuticals LLC. The label features usage instructions, dosage info, and contact details, including a barcode and Rx only designation.*

* 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.