Amlodipine And Atorvastatin Tablet, Film Coated
Product Images NDC 0378-4513

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Amlodipine And Atorvastatin (NDC 0378-4513). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan 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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Amlodipine Besylate And Atorvastatin Calcium Structural Formulae (Image 01)

Chemical structure diagram depicting the active ingredients Amlodipine besylate and Atorvastatin calcium. The left structure shows Amlodipine besylate with labeled asymmetric carbon center, and the right structure shows the Atorvastatin calcium molecule with associated hydration. Both are key components of the drug product Amlodipine and atorvastatin.*

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Figure 1. Kaplan-meier Analysis Of Composite Clinical Outcomes For Amlodipine Vs. Placebo (Image 02)

A line chart showing event rate over time in months (up to 24 months) for two groups: Amlodipine and Placebo. The graph includes a hazard ratio, p-value, and 95% confidence interval in a text box. The x-axis shows the number of patients at risk at different time points.*

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Figure 2. Effects On Primary Endpoint Of Amlodipine Vs. Placebo Across Sub-groups (Image 03)

A forest plot displaying hazard ratios with 95% confidence intervals comparing Amlodipine favorability versus placebo across various patient subgroups. Subgroups include overall patients, age categories, gender, baseline sitting systolic blood pressure, baseline vessel disease status, vessel stenosis presence, and PCI-stent strata, showing relative risk measures with confidence intervals on a horizontal axis.*

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Figure 3. Effect Of Atorvastatin 10 mg/day On Cumulative Incidence Of Non-fatal Myocardial Infarction Or Coronary Heart Disease Death (in Ascot-lla) (Image 04)

A line graph depicting cumulative incidence (%) over time in years comparing Atorvastatin and placebo groups. The graph shows Atorvastatin has a lower cumulative incidence than placebo up to 3.5 years, with a hazard ratio of 0.64 (0.50-0.83) and a p-value of 0.0005.*

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Figure 4. Effect Of Atorvastatin 10 mg/day On Time To Occurrence Of Major Cardiovascular Events (myocardial Infarction, Acute Chd Death, Unstable Angina, Coronary Revascularization, Or Stroke) In Cards (Image 05)

A line graph depicting cumulative hazard percentage over time (in years) to the first primary endpoint through four years of follow-up. The graph compares placebo and atorvastatin groups, showing lower cumulative hazard for atorvastatin. The chart includes a hazard ratio (HR 0.63) with confidence interval (0.48-0.83) and p-value (0.001).*

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Figure 5. Effect Of Atorvastatin 80 mg/day Vs. 10 mg/day On Time To Occurrence Of Major Cardiovascular Events (tnt) (Image 06)

A Kaplan-Meier curve comparing subjects experiencing the first major cardiovascular endpoint over five years between two atorvastatin doses, 10 mg (dashed line) and 80 mg (solid line). The graph shows the percentage of subjects experiencing the event versus time in years, with a hazard ratio of 0.78 (0.69-0.89) and a p-value of 0.0002 indicated.*

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Amlodipine Besylate And Atorvastatin Calcium Tablets 2.5 mg/10 mg Bottle Label (Image 07)

Label for Amlodipine and Atorvastatin 5 mg/10 mg film-coated tablets, USP, by Mylan Pharmaceuticals Inc. The label includes dosage information, storage instructions, NDC number 0378-4513-93, and states a package of 30 tablets. It advises dispensing in a tight, light-resistant container and includes a designated variable data area for lot and expiration dating.*

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Amlodipine Besylate And Atorvastatin Calcium Tablets 2.5 mg/20 mg Bottle Label (Image 08)

Label for Amlodipine and Atorvastatin Tablets USP 5 mg/20 mg by Mylan Pharmaceuticals Inc. The film-coated tablets come in a 30-count package. The label includes dosage details, storage instructions, and a child-resistant container warning, with an area reserved for variable lot and expiration data.*

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Amlodipine Besylate And Atorvastatin Calcium Tablets 2.5 mg/40 mg Bottle Label (Image 09)

Label for Amlodipine and Atorvastatin Tablets, USP, 5 mg/40 mg strength, film-coated oral tablets. The label indicates the product contains 30 tablets and is labeled by Mylan Pharmaceuticals Inc., Morgantown, WV, USA. It includes dosage information, storage instructions, and cautions for child-resistant packaging and prescription use.*

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Amlodipine Besylate And Atorvastatin Calcium Tablets 5 mg/10 mg Bottle Label (Image 10)

Label for Amlodipine and Atorvastatin Tablets, USP 5 mg/80 mg, film-coated tablets in a container of 30. Manufactured for Mylan Pharmaceuticals Inc. The label includes dosage strength, storage instructions, barcode, NDC 0378-4516-93, and child-resistant packaging details.*

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Amlodipine Besylate And Atorvastatin Calcium Tablets 5 mg/20 mg Bottle Label (Image 11)

Label for Amlodipine and atorvastatin tablets, USP 10 mg/10 mg, film-coated oral tablets supplied by Mylan Pharmaceuticals Inc. The package contains 30 tablets. The label includes dosing information, storage instructions, manufacturer details, and safety warnings about dispensing in a child-resistant container. The tablets are oval-shaped and blue with imprint 'AA 18'.*

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Amlodipine Besylate And Atorvastatin Calcium Tablets 5 mg/40 mg Bottle Label (Image 12)

Label for Amlodipine and atorvastatin tablets, USP 10 mg/20 mg, film-coated oral tablets by Mylan Pharmaceuticals Inc. The label indicates 30 tablets per container and includes storage, dispensing, and prescription-only instructions. It features Mylan branding, NDC 0378-4518-93, and a space for variable lot and expiration date data.*

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Amlodipine Besylate And Atorvastatin Calcium Tablets 5 mg/80 mg Bottle Label (Image 13)

Amlodipine and Atorvastatin Tablets, USP 10 mg/40 mg film-coated tablets carton label by Mylan Pharmaceuticals Inc. The label includes dosage information, storage instructions, and a 30-count tablet package. The label also specifies the product is prescription-only and includes barcode, NDC 0378-4519-93, and tamper-evident container instructions.*

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Amlodipine Besylate And Atorvastatin Calcium Tablets 10 mg/10 mg Bottle Label (Image 14)

Label for Amlodipine and Atorvastatin Tablets, USP, 10 mg/80 mg film-coated tablets, containing 30 tablets. Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV. The label includes dosage strength, NDC 0378-4520-93, storage instructions at 20° to 25°C, and child-resistant container warnings. It also displays the Mylan logo and notes the product is Rx only.*

* 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.