Galantamine Capsule, Extended Release
Product Images NDC 65862-745

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Galantamine (NDC 65862-745). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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 1: Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 21 Weeks (5 Months) Of Treatment (Galantamine Fig1)

A line chart illustrating the time-course change from baseline in ADAS-cog score over 21 weeks (5 months) of treatment. The graph compares placebo and Galantamine extended-release doses (8 mg/day, 16 mg/day, 24 mg/day), showing mean changes with error bars across weeks 0, 4, 13, and 21. The y-axis indicates improvement or decline in cognitive score, while the x-axis represents weeks of treatment.*

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Figure 10: Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 13 Weeks Of Treatment (Galantamine Fig10)

Line graph titled 'Time-Course of the Change From Baseline in ADAS-cog Score for Patients Completing 13 Weeks of Treatment.' It shows mean change from baseline in ADAS-cog score over 13 weeks for two groups: placebo and 24 or 32 mg/day dosage. The vertical axis represents change in ADAS-cog score from -2 to 2, with improvement and decline indicated. The horizontal axis represents weeks of treatment at 0, 4, and 13 weeks. The graph shows improvement for the 24 or 32 mg/day group over time, while placebo remains near baseline.*

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Figure 11: Cumulative Percentage Of Patients Completing 13 Weeks Of Double-blind Treatment With Specified Changes From Baseline In Adas-cog Scores. The Percentages Of Randomized Patients Who Completed The Study Were: Placebo 90%, 24 To 32 mg/day 67%. (Galantamine Fig11)

A cumulative percentage graph showing patients completing 13 weeks of double-blind treatment with Galantamine capsules extended release, at 24 or 32 mg/day, versus placebo. The X-axis represents ADAS-cog change from baseline and the Y-axis the cumulative percentage of patients. Two curves compare placebo and active drug groups across the score changes.*

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Figure 12: Distribution Of Cibic-plus Ratings At Week 13 (Galantamine Fig12)

A vertical bar graph titled 'Distribution of CIBIC-plus Ratings at Week 13,' showing the percentage of patients plotted against CIBIC-plus Rating categories. Two data sets are displayed: Placebo and 24 or 32 mg/day. Categories range from Markedly Improved to Markedly Worse, illustrating patient distribution across efficacy ratings.*

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Package Label-principal Display Panel (8 mg (30 Capsules Bottle))

Label for Galantamine Extended-Release Capsules, USP 8 mg by Aurobindo Pharma Limited, distributed by Aurobindo Pharma USA, Inc. The label states it contains 30 capsules and includes the NDC 65862-744-30. It indicates the capsule contains 8 mg galantamine and 10.25 mg galantamine hydrobromide, with storage instructions and a barcode on the right.*

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Package Label-principal Display Panel (16 mg (30 Capsules Bottle))

Label for Galantamine Extended-Release Capsules, USP 16 mg by Aurobindo Pharma Limited. The label indicates 30 capsules in the package, with each capsule containing 16 mg galantamine as galantamine hydrobromide. The label includes storage instructions, distributor details (Aurobindo Pharma USA, Inc., New Jersey), and a barcode. It notes the product is Rx only and made in India.*

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Package Label-principal Display Panel (24 mg (30 Capsules Bottle))

Label for Galantamine Extended-Release Capsules USP 24 mg by Aurobindo Pharma Limited. The package contains 30 capsules, with each extended-release capsule containing 24 mg galantamine as 30.76 mg galantamine hydrobromide. The label includes storage instructions, dosage notation, and distributor details for Aurobindo Pharma USA, Inc. A barcode and coding area are also present.*

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Figure 2: Cumulative Percentage Of Patients Completing 21 Weeks Of Double-blind Treatment With Specified Changes From Baseline In Adas-cog Scores. The Percentages Of Randomized Patients Who Completed The Study Were: Placebo 84%, 8 mg/day 77%, 16 mg/day 78% And 24 mg/day 78%. (Galantamine Fig2)

A line graph showing the cumulative percentage of patients completing 21 weeks of double-blind treatment with Galantamine at dosages of 8 mg/day, 16 mg/day, and 24 mg/day, compared to placebo, plotted against ADAS-cog score changes from baseline. The x-axis represents ADAS-cog change from baseline and the y-axis the cumulative percentage of patients, with vertical markers at no change, and -4, -7, and -10 points.*

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Figure 3: Distribution Of Cibic-plus Ratings At Week 21 (Galantamine Fig3)

A bar chart titled 'Distribution of CIBIC-plus Ratings at Week 21' showing the percentage of patients for different CIBIC-plus rating categories. The chart compares placebo and three dosage groups of galantamine (8 mg/day, 16 mg/day, and 24 mg/day) across categories: Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse.*

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Figure 4: Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 26 Weeks Of Treatment (Galantamine Fig4)

A line graph titled 'Time-Course of the Change From Baseline in ADAS-cog Score for Patients Completing 26 Weeks of Treatment.' It depicts the mean change from baseline in ADAS-cog scores over 0, 3, 13, and 26 weeks for three groups: placebo, 24 mg/day, and 32 mg/day doses. The vertical axis shows improvement and decline in scores, while the horizontal axis represents weeks of treatment. The graph includes error bars and a legend differentiating the three groups.*

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Figure 5: Cumulative Percentage Of Patients Completing 26 Weeks Of Double-blind Treatment With Specified Changes From Baseline In Adas-cog Scores. The Percentages Of Randomized Patients Who Completed The Study Were: Placebo 81%, 24 mg/day 68%, And 32 mg/day 58%. (Galantamine Fig5)

A cumulative percentage line graph showing patients completing 26 weeks of double-blind treatment with changes from baseline in ADAS-cog scores. The graph compares placebo, 24 mg/day, and 32 mg/day groups with ADAS-cog change from baseline on the x-axis and cumulative percentage of patients on the y-axis, illustrating different response levels over time.*

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Figure 6: Distribution Of Cibic-plus Ratings At Week 26 (Galantamine Fig6)

A bar chart titled 'Distribution of CIBIC-plus Ratings at Week 26' showing the percentage of patients on the y-axis and CIBIC-plus ratings on the x-axis. It compares three groups: Placebo, 24 mg/day, and 32 mg/day, across categories from 'Markedly Improved' to 'Markedly Worse.' The chart visualizes the distribution of patient responses to treatment over 26 weeks.*

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Figure 7: Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 26 Weeks Of Treatment (Galantamine Fig7)

A line graph illustrating the time-course change from baseline in ADAS-cog score for patients completing 26 weeks of treatment. The x-axis represents weeks of treatment (0, 3, 13, 26), and the y-axis shows mean change from baseline in ADAS-cog score, with negative values indicating improvement and positive values indicating decline. Three groups are compared: placebo, 24 mg/day, and 32 mg/day dosing.*

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Figure 8: Cumulative Percentage Of Patients Completing 26 Weeks Of Double-blind Treatment With Specified Changes From Baseline In Adas-cog Scores. The Percentages Of Randomized Patients Who Completed The Study Were: Placebo 87%, 24 mg/day 80%, And 32 mg/day 75%. (Galantamine Fig8)

A cumulative percentage line graph showing patients completing 26 weeks of double-blind treatment with Galantamine or placebo, plotted against changes from baseline in ADAS-cog scores. The x-axis represents ADAS-cog change from baseline, and the y-axis shows cumulative percentage of patients. Three lines compare placebo, 24 mg/day, and 32 mg/day treatment groups, illustrating higher completion percentages with treatment.*

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Figure 9: Distribution Of Cibic-plus Rating At Week 26 (Galantamine Fig9)

A bar chart titled 'Distribution of CIBIC-plus Rating at Week 26' shows percentages of patients along the vertical axis and CIBIC-plus rating categories on the horizontal axis. The ratings range from Markedly Improved to Markedly Worse. Three groups are compared: Placebo, 24 mg/day, and 32 mg/day, with different bar patterns. The chart illustrates patient outcome distributions after 26 weeks across these treatment groups.*

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Galantamine-str (Galantamine Str)

Chemical structure of Galantamine hydrobromide shown. The diagram depicts the molecular arrangement including methoxy, hydroxyl, and nitrogen groups as part of the Galantamine compound.*

* 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.