Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020582
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOLLISTIM FOLLITROPIN ALFA/BETA 75 IU/VIAL INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Discontinued None No No
FOLLISTIM FOLLITROPIN ALFA/BETA 150 IU/VIAL INJECTABLE;INTRAMUSCULAR, 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
09/29/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20582_FOLLISTIM%2075IU%20AND%20150IU%20VIALS_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020582_follistim_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/2002 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20582s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20582s6ltr.pdf
05/25/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1999 SUPPL-2 Manufacturing (CMC) Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20582-S002_FOLLISTIM_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020582s002_follistim_toc.cfm
11/18/1998 SUPPL-1 Manufacturing (CMC)-Formulation Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20582-S001_FOLLISTIM_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020582s001_follistim_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/26/2002 SUPPL-6 Tentative Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20582s006lbl.pdf

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