Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021663
Company: FERRING
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 |