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 | 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 | No | No |
| GONAL-F | FOLLITROPIN ALFA/BETA | 450 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 |
|---|---|---|---|---|---|---|---|
| 09/29/1997 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2023 | SUPPL-84 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020378s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020378Orig1s084ltr.pdf | |
| 12/31/2020 | SUPPL-75 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020378Orig1s045,s067,s075ltr.pdf | |
| 11/15/2016 | SUPPL-72 | Supplement |
Label is not available on this site. |
||
| 03/03/2015 | SUPPL-69 | Supplement |
Label is not available on this site. |
||
| 02/09/2015 | SUPPL-68 | Supplement |
Label is not available on this site. |
||
| 12/31/2020 | SUPPL-67 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020378Orig1s045,s067,s075ltr.pdf | |
| 08/11/2014 | SUPPL-65 | Supplement |
Label is not available on this site. |
||
| 12/19/2013 | SUPPL-64 | Supplement |
Label is not available on this site. |
||
| 12/11/2013 | SUPPL-63 | Supplement |
Label is not available on this site. |
||
| 09/20/2013 | SUPPL-62 | Supplement |
Label is not available on this site. |
||
| 01/30/2014 | SUPPL-61 | Supplement |
Label is not available on this site. |
||
| 04/04/2013 | SUPPL-60 | Supplement |
Label is not available on this site. |
||
| 02/26/2013 | SUPPL-59 | Supplement |
Label is not available on this site. |
||
| 02/29/2016 | SUPPL-58 | Supplement |
Label is not available on this site. |
||
| 02/20/2013 | SUPPL-57 | Supplement |
Label is not available on this site. |
||
| 02/19/2013 | SUPPL-56 | Supplement |
Label is not available on this site. |
||
| 02/14/2013 | SUPPL-55 | Supplement |
Label is not available on this site. |
||
| 02/08/2013 | SUPPL-54 | Supplement |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-53 | Supplement |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-52 | Supplement |
Label is not available on this site. |
||
| 01/23/2013 | SUPPL-51 | Supplement |
Label is not available on this site. |
||
| 02/06/2013 | SUPPL-50 | Supplement |
Label is not available on this site. |
||
| 01/18/2013 | SUPPL-47 | Supplement |
Label is not available on this site. |
||
| 12/31/2020 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020378Orig1s045,s067,s075ltr.pdf | |
| 11/19/2015 | SUPPL-43 | Supplement |
Label is not available on this site. |
||
| 08/13/2013 | SUPPL-42 | Supplement |
Label is not available on this site. |
||
| 07/16/2003 | SUPPL-29 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
| 10/07/2002 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
| 07/15/2002 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 03/25/2004 | SUPPL-15 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 03/26/2001 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
| 10/26/2000 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 11/08/2000 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 01/05/2000 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-378S-006_review.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20378S6LTR.PDF | |
| 01/05/2000 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 06/23/1999 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 05/25/2000 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 11/10/1998 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-1 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/21/2023 | SUPPL-84 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020378s084lbl.pdf | |
| 11/21/2023 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020378s084lbl.pdf | |
| 11/21/2023 | SUPPL-84 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020378s084lbl.pdf | |
| 12/31/2020 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf | |
| 12/31/2020 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf | |
| 12/31/2020 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf | |
| 03/25/2004 | SUPPL-15 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20378scf015_gonal_lbl.pdf | |
| 05/24/2000 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-378S-006_review.pdf |