Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021197
Company: EMD SERONO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETROTIDE CETRORELIX EQ 0.25MG BASE/ML INJECTABLE;INJECTION Prescription None Yes Yes
CETROTIDE CETRORELIX EQ 3MG BASE/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
08/11/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21197ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-197_Cetrotide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/13/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/15/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/29/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/04/2008 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021197s010ltr.pdf
04/30/2004 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf
04/30/2004 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf
04/30/2004 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf
12/13/2000 SUPPL-2 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
04/04/2008 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf
08/11/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf

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