Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021663
Company: FERRING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MENOPUR MENOTROPINS (FSH;LH) 75 IU/VIAL;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
10/29/2004 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21663lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21663ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-663_MenopurTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2016 SUPPL-26 Supplement

Label is not available on this site.

01/20/2015 SUPPL-21 Supplement

Label is not available on this site.

07/11/2014 SUPPL-19 Supplement

Label is not available on this site.

06/11/2013 SUPPL-16 Supplement

Label is not available on this site.

01/24/2013 SUPPL-15 Supplement

Label is not available on this site.

02/19/2014 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021663s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021663Orig1s014ltr.pdf
03/20/2006 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021663S001, 021663S00ltr.pdf
03/20/2006 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021663S001, 021663S00ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/19/2014 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021663s014lbl.pdf
03/20/2006 SUPPL-2 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf
03/20/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf
10/29/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21663lbl.pdf

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