Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 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
03/25/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD 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
02/10/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

04/29/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/11/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/19/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/11/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/04/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/19/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/14/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/31/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/23/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/06/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/17/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/17/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/17/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/05/2007 SUPPL-7 Labeling 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 Manufacturing (CMC)-Control 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
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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