Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020378
Company: EMD SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GONAL-F FOLLITROPIN ALFA/BETA 75 IU/VIAL INJECTABLE;SUBCUTANEOUS Discontinued None No No
GONAL-F FOLLITROPIN ALFA/BETA 150 IU/VIAL INJECTABLE;SUBCUTANEOUS Discontinued None No No
GONAL-F FOLLITROPIN ALFA/BETA 37.5 IU/VIAL INJECTABLE;SUBCUTANEOUS Discontinued None No No
GONAL-F FOLLITROPIN ALFA/BETA 1,050 IU/VIAL INJECTABLE;SUBCUTANEOUS Prescription None Yes No
GONAL-F FOLLITROPIN ALFA/BETA 450 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
09/29/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2016 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

03/03/2015 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

02/09/2015 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

08/11/2014 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

12/19/2013 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

12/11/2013 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

09/20/2013 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

01/30/2014 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

04/04/2013 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

02/26/2013 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

02/29/2016 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

02/20/2013 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

02/19/2013 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

02/14/2013 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

01/31/2013 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

01/23/2013 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

02/06/2013 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

01/18/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

11/19/2015 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/13/2013 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/16/2003 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20378slr026,029ltr.pdf
07/16/2003 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20378slr026,029ltr.pdf
10/16/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/08/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/2004 SUPPL-15 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20378scf015_gonal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20378scf015ltr.pdf
07/23/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/26/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/08/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/28/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/2000 SUPPL-6 Efficacy-New Indication Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20378S6LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-378S-006_review.pdf
01/05/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/25/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/25/2004 SUPPL-15 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20378scf015_gonal_lbl.pdf

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