Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021684
Company: EMD SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GONAL-F RFF REDI-JECT FOLLITROPIN ALFA/BETA 300 IU/0.5ML INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
GONAL-F RFF REDI-JECT FOLLITROPIN ALFA/BETA 450 IU/0.75ML INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
GONAL-F RFF REDI-JECT FOLLITROPIN ALFA/BETA 900 IU/1.5ML 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
05/25/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21684_gonal-f_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21684ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021684s000_GonalTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/06/2017 SUPPL-38 Labeling-Container/Carton Labels

Label is not available on this site.

10/16/2013 SUPPL-36 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021684s036lbl.pdf
04/04/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/19/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/14/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/31/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/23/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/06/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/11/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/06/2007 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021684s008ltr.pdf
12/18/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021684s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021684s007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/16/2013 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021684s036lbl.pdf
12/18/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021684s007lbl.pdf
05/25/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21684_gonal-f_lbl.pdf

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