Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021538
Company: EMERGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACCRETROPIN SOMATROPIN RECOMBINANT 5MG/ML (5MG/ML) INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/23/2008 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021538lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021538s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021538_accretropin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021538s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021538s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021538Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/13/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021538s002lbl.pdf
01/23/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021538lbl.pdf

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