`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
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`Label and Approval History
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`Drug Name(s)
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`ZORBTIVE
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`FDA Application No.
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`(NDA) 021597
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`Active Ingredient(s)
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`SOMATROPIN RECOMBINANT
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`Company
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`EMD SERONO
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`Go to Approval History
`
`Label Information
`
`What information does a label include?
`Note: Not all labels are available in electronic format from FDA.
`
`View the label approved on 12/01/2003 (PDF) for NDA no. 021597
`
`To see older, previously-approved labels, go to the "Approval History" section of this page.
`Older labels are for historical information only and should not be used for clinical purposes.
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`Approval History
`NDA 021597
`
`Note: Not all reviews are available in electronic format from FDA.
`Older labels are for historical information only, and should not be used for clinical purposes.
`Approval dates can only be verified from 1984 to the present.
`
`Click on a column header to re-sort the table:
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` Download data
`
`Action
`Date
`
`Supplement
`Number
`
`12/01/2003
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`000
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`Approval
`Type
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`Approval
`
`Letters,
`Reviews,
`Labels,
`Patient Package Insert
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`Label (PDF)
`Letter (PDF)
`Review
`
`Note
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`
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`Note: If you need help accessing information in different file formats, see Instructions for Downloading
`Viewers and Players
`
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