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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021149
Company: EMD SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OVIDREL CHORIOGONADOTROPIN ALFA 0.25MG/VIAL INJECTABLE;INJECTION Discontinued None No No
OVIDREL CHORIOGONADOTROPIN ALFA EQ 0.25MG /0.5ML INJECTABLE;SUBCUTANEOUS Prescription None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/02/2010 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf
07/30/2007 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf
09/20/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf
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