Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021149
Company: EMD SERONO
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 |
| 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 |