Drugs@FDA: FDA-Approved Drugs
Company: EMD SERONO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OVIDREL | CHORIOGONADOTROPIN ALFA | 0.25MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
OVIDREL | CHORIOGONADOTROPIN ALFA | EQ 0.25MG /0.5ML | 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 |
---|---|---|---|---|---|---|---|
09/20/2000 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21149ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-149_Ovidrel.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/30/2015 | SUPPL-40 | Supplement |
Label is not available on this site. |
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12/11/2014 | SUPPL-39 | Supplement |
Label is not available on this site. |
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12/19/2013 | SUPPL-37 | Supplement |
Label is not available on this site. |
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12/11/2013 | SUPPL-36 | Supplement |
Label is not available on this site. |
||
04/11/2013 | SUPPL-35 | Supplement |
Label is not available on this site. |
||
04/05/2013 | SUPPL-34 | Supplement |
Label is not available on this site. |
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01/31/2013 | SUPPL-33 | Supplement |
Label is not available on this site. |
||
02/08/2013 | SUPPL-32 | Supplement |
Label is not available on this site. |
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01/15/2013 | SUPPL-31 | Supplement |
Label is not available on this site. |
||
01/31/2013 | SUPPL-30 | Supplement |
Label is not available on this site. |
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01/15/2013 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
12/10/2012 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
12/13/2012 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
06/02/2010 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021149s020ltr.pdf | |
07/09/2013 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
07/30/2007 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021149s013ltr.pdf | |
07/14/2003 | SUPPL-6 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21149slr006ltr.pdf |
05/15/2002 | 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 |
---|---|---|---|---|---|
06/02/2010 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf | |
07/30/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf | |
09/20/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf |