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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021765
Company: EMD SERONO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GONAL-F FOLLITROPIN ALFA/BETA 37.5 IU/VIAL INJECTABLE;SUBCUTANEOUS Discontinued None No No
GONAL-F FOLLITROPIN ALFA/BETA 150 IU/VIAL INJECTABLE;SUBCUTANEOUS Discontinued None No No
GONAL-F RFF FOLLITROPIN ALFA/BETA 75 IU/VIAL INJECTABLE;SUBCUTANEOUS Prescription 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
03/25/2004 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21765_follitropin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21765ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021765s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/13/2023 SUPPL-51 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021765s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021765Orig1s051ltr.pdf
12/31/2020 SUPPL-44 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021765s013s014s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021765s013s014s044ltr.pdf
02/10/2016 SUPPL-40 Supplement

Label is not available on this site.
04/29/2015 SUPPL-39 Supplement

Label is not available on this site.
08/11/2014 SUPPL-35 Supplement

Label is not available on this site.
12/19/2013 SUPPL-34 Supplement

Label is not available on this site.
12/11/2013 SUPPL-32 Supplement

Label is not available on this site.
04/04/2013 SUPPL-29 Supplement

Label is not available on this site.
02/19/2013 SUPPL-26 Supplement

Label is not available on this site.
02/14/2013 SUPPL-25 Supplement

Label is not available on this site.
02/08/2013 SUPPL-24 Supplement

Label is not available on this site.
01/31/2013 SUPPL-22 Supplement

Label is not available on this site.
01/23/2013 SUPPL-21 Supplement

Label is not available on this site.
02/06/2013 SUPPL-20 Supplement

Label is not available on this site.
01/17/2013 SUPPL-19 Supplement

Label is not available on this site.
01/17/2013 SUPPL-18 Supplement

Label is not available on this site.
12/31/2020 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021765s013s014s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021765s013s014s044ltr.pdf
12/31/2020 SUPPL-13 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020021765s013s014s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021765s013s014s044ltr.pdf
11/17/2015 SUPPL-11 Supplement

Label is not available on this site.
07/05/2007 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021765s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021765s007_ltr.pdf
12/20/2005 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021765s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021765s004ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/13/2023 SUPPL-51 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021765s051lbl.pdf
11/13/2023 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021765s051lbl.pdf
11/13/2023 SUPPL-51 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021765s051lbl.pdf
12/31/2020 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021765s013s014s044lbl.pdf
12/31/2020 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021765s013s014s044lbl.pdf
12/31/2020 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020021765s013s014s044lbl.pdf
07/05/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021765s007lbl.pdf
12/20/2005 SUPPL-4 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021765s004lbl.pdf
03/25/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21765_follitropin_lbl.pdf
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