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Displaying 129-143 of 357 results

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Letter

Document REMODULIN, 021272, Letter (Orange Book Aug. 19, 2020)

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Letter

Document ORENITRAM, 203496, Letter (Orange Book Oct. 18, 2019)

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Label

Document ORENITRAM, 203496, Label (Orange Book Oct. 18, 2019)

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TYVASO

Docket 022387, Orange Book (July 30, 2009)

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Review Summary Review

Document REMODULIN, 208276, Review Summary Review (Orange Book Jul. 30, 2018)

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Review Approval Letters

Document REMODULIN, 208276, Review Approval Letters (Orange Book Jul. 30, 2018)

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Review Clinical Pharmacology and Biopharmaceutics Reviews

Document REMODULIN, 208276, Review Clinical Pharmacology and Biopharmaceutics Reviews (Orange Book Jul. 30, 2018)

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Review Other Reviews

Document REMODULIN, 208276, Review Other Reviews (Orange Book Jul. 30, 2018)

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Review Statistical Reviews

Document REMODULIN, 208276, Review Statistical Reviews (Orange Book Jul. 30, 2018)

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Review Printed Labeling

Document REMODULIN, 208276, Review Printed Labeling (Orange Book Jul. 30, 2018)

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Review Clinical Reviews

Document REMODULIN, 208276, Review Clinical Reviews (Orange Book Jul. 30, 2018)

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Label

Document REMODULIN, 208276, Label (Orange Book Jul. 30, 2018)

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Review Product Quality Reviews

Document REMODULIN, 208276, Review Product Quality Reviews (Orange Book Jul. 30, 2018)

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Review Non-Clinical Reviews

Document REMODULIN, 208276, Review Non-Clinical Reviews (Orange Book Jul. 30, 2018)

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Review Other Action Letters

Document REMODULIN, 208276, Review Other Action Letters (Orange Book Jul. 30, 2018)

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