Drugs@FDA: FDA-Approved Drugs
Company: EMD SERONO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GONAL-F | FOLLITROPIN ALFA/BETA | 37.5 IU/VIAL | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
GONAL-F | FOLLITROPIN ALFA/BETA | 150 IU/VIAL | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
GONAL-F RFF | FOLLITROPIN ALFA/BETA | 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 |
---|---|---|---|---|---|---|---|
03/25/2004 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21765_follitropin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21765ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021765s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/13/2023 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021765s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021765Orig1s051ltr.pdf | |
12/31/2020 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021765s013s014s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021765s013s014s044ltr.pdf | |
02/10/2016 | SUPPL-40 | Supplement |
Label is not available on this site. |
||
04/29/2015 | SUPPL-39 | Supplement |
Label is not available on this site. |
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08/11/2014 | SUPPL-35 | Supplement |
Label is not available on this site. |
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12/19/2013 | SUPPL-34 | Supplement |
Label is not available on this site. |
||
12/11/2013 | SUPPL-32 | Supplement |
Label is not available on this site. |
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04/04/2013 | SUPPL-29 | Supplement |
Label is not available on this site. |
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02/19/2013 | SUPPL-26 | Supplement |
Label is not available on this site. |
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02/14/2013 | SUPPL-25 | Supplement |
Label is not available on this site. |
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02/08/2013 | SUPPL-24 | Supplement |
Label is not available on this site. |
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01/31/2013 | SUPPL-22 | Supplement |
Label is not available on this site. |
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01/23/2013 | SUPPL-21 | Supplement |
Label is not available on this site. |
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02/06/2013 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
01/17/2013 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
01/17/2013 | SUPPL-18 | Supplement |
Label is not available on this site. |
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12/31/2020 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021765s013s014s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021765s013s014s044ltr.pdf | |
12/31/2020 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020021765s013s014s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021765s013s014s044ltr.pdf | |
11/17/2015 | SUPPL-11 | Supplement |
Label is not available on this site. |
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07/05/2007 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021765s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021765s007_ltr.pdf | |
12/20/2005 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021765s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021765s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/13/2023 | SUPPL-51 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021765s051lbl.pdf | |
11/13/2023 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021765s051lbl.pdf | |
11/13/2023 | SUPPL-51 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021765s051lbl.pdf | |
12/31/2020 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021765s013s014s044lbl.pdf | |
12/31/2020 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021765s013s014s044lbl.pdf | |
12/31/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020021765s013s014s044lbl.pdf | |
07/05/2007 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021765s007lbl.pdf | |
12/20/2005 | SUPPL-4 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021765s004lbl.pdf |
03/25/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21765_follitropin_lbl.pdf |