Geoff LeCain
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Articles
Recent activity by Geoff LeCain-
Labeler and Registrant Information
The Labeler & Registrant tab allows users to associate and manage the Labeler Code and if necessary the Registrant for the product. Registrants that are marked as confidential will not display on ...
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How do I send Intagras a question or report a bug from the SPL Portal?
Answer: Select the Actions drop-down menu and select Contact Us to send a question, report a bug, suggest a new feature, or add an ingredient approved by the FDA not found in our database. Simply s...
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Establishments Information
The “Establishments” tab allows users to associate Establishments and business operations with the product. Establishments that are marked as confidential will not display on the public Daily Med....
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Why am I receiving an error regarding my SPL Headers?
Answer: When entering data into the Product Data Elements section, specifically the proprietary and Establishment name fields, spelling conventions should remain consistent. The proprietary and Est...
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Product Data Elements
The “Product Data Elements” section allows users to further define each manufactured product. The “Product Validation” section displays the result of the last validation for all of the data in the...
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Individual Manufactured Product
Individual Manufactured Product The individual manufactured product is broken down into 6 distinct areas: Manufactured Product –NDC Product Code, form code, proprietary name, marketing category an...
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Why is/isn’t “RECENT MAJOR CHANGES” displaying in the table of contents?
Answer: The SPL style sheet populates the table of contents with the text associated with the “Title” elements of each major section. To prevent the “Recent Major Changes” text from showing in the ...
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Manufactured Product
The “Manufactured Product” section allows users to populate the following data associated to each manufactured product formulation: NDC Product Code Form Code Proprietary Name Marketing Category S...
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How do I center tables?
Answer: The SPL schema does not support centering tables, therefore, the SPL Portal application does not allow for a table to be centered in relation to the body of the document. The text in the ce...
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Active Ingredient(s)
The “Active Ingredients” section allows users to define the active ingredient based on the FDA rules. Users should define the basis of strength, active ingredient, strength, and active moiety. Th...