Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021273
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOLLISTIM AQ FOLLITROPIN ALFA/BETA 75 IU/0.5ML INJECTABLE;SUBCUTANEOUS Discontinued None No No
FOLLISTIM AQ FOLLITROPIN ALFA/BETA 150 IU/0.5ML INJECTABLE;SUBCUTANEOUS 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
08/26/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021273lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021273ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021273s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/19/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/28/2010 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021273s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021273s006ltr.pdf
12/24/2008 SUPPL-3 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021273s003ltr.pdf
08/08/2006 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2010 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021273s006lbl.pdf
08/26/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021273lbl.pdf

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