| 1-3-1-1-change-of-address-or-name.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-1-2-change-in-contact-agent.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-1-3-change-in-sponsor.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-1-4-transfer-of-obligations.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-1-5-change-in-ownership-of-an-application.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-2-field-copy-certification.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-3-debarment-certification.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-4-financial-certification-and-disclosure.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-5-1-patent-exclusivity.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-5-2-patent-certification.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-3-5-3-exclusivity-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-4-1-letter-authorization.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-4-2-statement-of-right-of-reference.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-4-3-list-of-authorized-persons-to-incorporate-by-reference.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-4-4-cross-reference-to-other-applications.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-5-1-withdrawal-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-5-2-inactivation-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-5-3-reactivation-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-5-4-reinstatement-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-5-5-withdrawal-of-an-unapproved-NDA.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-5-6-withdrawal-of-listed-drug.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-5-7-request-for-withdrawal-of-application-approval.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-6-1-meeting-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-6-2-meeting-background-materials.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-6-3-correspondence-regarding-meetings.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-7-1-fast-track-designation-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-7-2-fast-track-designation-withdrawal-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-7-3-rolling-review-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-8-1-clinical-study.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-8-2-carcinogenicity-study.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-8-3-stability-study.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-9-1-request-for-waiver-of-pediatric-studies.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-9-2-request-for-deferral-of-pediatric-studies.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-9-3-request-for-pediatric-exclusivity-determination.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-9-4-proposed-pediatric-study-request.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-9-5-proposal-for-written-agreement.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-9-6-other-ped-correspondence.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-10-1-request-for-dispute-resolution.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-10-2-correspondence-related-to-dispute-resolution.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-11-1-quality-information-amendment.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-11-2-safety-information-amendment.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-11-3-efficacy-information-amendment.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-1-pre-ind-correspondence.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-2-request-to-charge.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-3-notification-of-charging-under-treatment-ind.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-4-request-for-comments-and-advice.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-5-request-for-waiver.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-6-exemption-from-informed-consent.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-7-public-disclosure-statement-informed-consent.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-8-correspondence-regaring-exception.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-9-notification-of-discontinuation-of-clinical-trial.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-10-generic-drug-enforcement-act.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-11-basis-for-submission-statement.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-12-comparison-of-generic-and-RLD.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-13-request-for-waiver-in-vivo.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-14-environmental-analysis.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-15-request-waiver-vivo-bioavailability.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-12-16-field-alert-reports.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-1-summary-for-nonclinical-studies.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-2-summary-of-clinical-pharmacology-information.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-3-summary-of-safety-information.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-4-summary-of-labeling-changes.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-5-summary-of-manufacturing-changes.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-6-summary-of-microbiological-changes.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-7-summary-of-other-significant-new-information.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-8-individual-study-information.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-9-general-investigational-plan.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-10-foreign-marketing-history.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-11-distribution-data.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-12-status-of-postmarketing-study-commitments.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-13-status-of-other-postparketing-studies.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-13-14-log-of-outstanding-regulatory-business.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-1-1-draft-carton-and-container-labels.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-1-2-annotated-draft-labeling-text.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-1-3-draft-labeling-text.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-1-4-label-comprehension-studies.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-1-5-labeling-history.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-2-1-final-carton-or-container-label.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-2-2-final-package-insert.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-2-3-final-labeling-text.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-3-1-annotated-comparison-with-listed-drug.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-3-2-approved-labeling-text-for-listed-drug.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-3-3-labeling-text-for-reference-listed-drug.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-4-1-investigator-brochure.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-4-2-inv-drug-labeling.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-14-5-foreign-labeling.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-15-promotional-material.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| 1-16-risk-management-plan.doc
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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| US M1 Template List.pdf
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C:\Program Files\Liquent\Author\CTDtemplates\Module 1 US
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