Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 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
09/20/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21149ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-149_Ovidrel.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2015 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

12/11/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/19/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/11/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/11/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/05/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/31/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/15/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/31/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/15/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/10/2012 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/13/2012 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/02/2010 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021149s020ltr.pdf
07/09/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/30/2007 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021149s013ltr.pdf
07/14/2003 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21149slr006ltr.pdf
05/15/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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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