| Applicant
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The name of the applicant/HCR (Holder of Certificate of Registration) submitting the eCTD.
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| Application Number
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The number issued for the product by the MCC (Medicines Control Council). The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided.
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| Dosage Form
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The dosage form of the medicinal product. Multiple comma-separated values can be provided.
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| Duplicated Applications (Proprietary Names/Application Numbers)
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The name of the multiple/duplicate applications of the medicinal product (include, even if the name is not yet approved) plus the application number(s) of the duplicate applications. Multiple paired values can be provided.
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| eCTD Sequence
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The sequence number of the data submission. The default is from the Sequence Code, but can be overridden.
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| INN
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The INN of the API(s) accompanied by its salt or hydrate form (if relevant) or chemical description of the API(s). Multiple comma-separated values can be provided.
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| Proprietary Name
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The name of the medicinal product. Include even if not yet approved. Multiple comma-separated values can be provided.
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| Related Sequence
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The sequence number of a previous submission to which the submission relates. Multiple comma-separated values can be provided.
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| Submission Type / Proof of Efficacy
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The type of regulatory submission to which the data submission relates followed. The type of regulatory submission is followed by data type submitted as proof of efficacy, and a description of the data type if "other" is selected as data type. Multiple paired values can be provided for the Proof of Efficacy, each bound to the specific submission type.
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