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Displaying 84-98 of 223 results

ORENITRAM

Docket 203496, Orange Book (Dec. 20, 2013)

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Review Administrative and Correspondence Documents

Document TYVASO DPI, 214324, Review Administrative and Correspondence Documents (Orange Book May. 23, 2022)

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Review Non-Clinical Reviews

Document TYVASO DPI, 214324, Review Non-Clinical Reviews (Orange Book May. 23, 2022)

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Review Product Quality Reviews

Document TYVASO DPI, 214324, Review Product Quality Reviews (Orange Book May. 23, 2022)

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Review Cross Discipline Team Leader Review

Document TYVASO DPI, 214324, Review Cross Discipline Team Leader Review (Orange Book May. 23, 2022)

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Review OfficerEmployee List

Document TYVASO DPI, 214324, Review OfficerEmployee List (Orange Book May. 23, 2022)

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Review Clinical Pharmacology and Biopharmaceutics Reviews

Document TYVASO DPI, 214324, Review Clinical Pharmacology and Biopharmaceutics Reviews (Orange Book May. 23, 2022)

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Review Other Action Letters

Document TYVASO DPI, 214324, Review Other Action Letters (Orange Book May. 23, 2022)

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Review Proprietary Name Reviews

Document TYVASO DPI, 214324, Review Proprietary Name Reviews (Orange Book May. 23, 2022)

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Review Other Reviews

Document TYVASO DPI, 214324, Review Other Reviews (Orange Book May. 23, 2022)

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Review Printed Labeling

Document TYVASO DPI, 214324, Review Printed Labeling (Orange Book May. 23, 2022)

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Review Risk Assessment and Risk Mitigation Reviews

Document TYVASO DPI, 214324, Review Risk Assessment and Risk Mitigation Reviews (Orange Book May. 23, 2022)

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Review Clinical Reviews

Document TYVASO DPI, 214324, Review Clinical Reviews (Orange Book May. 23, 2022)

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Review Approval Letters

Document TYVASO DPI, 214324, Review Approval Letters (Orange Book May. 23, 2022)

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Label

Document TYVASO DPI, 214324, Label (Orange Book May. 23, 2022)

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