Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021211
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOLLISTIM AQ FOLLITROPIN ALFA/BETA 300 IU/0.36ML INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
FOLLISTIM AQ FOLLITROPIN ALFA/BETA 600 IU/0.72ML INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
FOLLISTIM AQ FOLLITROPIN ALFA/BETA 150 IU/0.18ML INJECTABLE;SUBCUTANEOUS Discontinued None No No
FOLLISTIM AQ FOLLITROPIN ALFA/BETA 900 IU/1.08ML 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
03/23/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21211_Follistim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21211ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021211s000_FollistimTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2016 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/15/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/09/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/22/2011 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021211s011ltr.pdf
06/28/2010 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021211s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021211s007ltr.pdf
02/11/2005 SUPPL-2 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21211s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21211s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/22/2011 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf
06/28/2010 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021211s007lbl.pdf
02/11/2005 SUPPL-2 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21211s002lbl.pdf
03/23/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21211_Follistim_lbl.pdf

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