Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021597
Company: EMD SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZORBTIVE SOMATROPIN RECOMBINANT 4MG/VIAL INJECTABLE;INJECTION Discontinued None No No
ZORBTIVE SOMATROPIN RECOMBINANT 5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
ZORBTIVE SOMATROPIN RECOMBINANT 6MG/VIAL INJECTABLE;INJECTION Discontinued None No No
ZORBTIVE SOMATROPIN RECOMBINANT 8.8MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/01/2003 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21597,20604slr026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021597s000_ZorbtiveTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/01/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf

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