Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021211
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOLLISTIM AQ | FOLLITROPIN ALFA/BETA | 300 IU/0.36ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| FOLLISTIM AQ | FOLLITROPIN ALFA/BETA | 600 IU/0.72ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| FOLLISTIM AQ | FOLLITROPIN ALFA/BETA | 150 IU/0.18ML | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| FOLLISTIM AQ | FOLLITROPIN ALFA/BETA | 900 IU/1.08ML | 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 |
|---|---|---|---|---|---|---|---|
| 03/23/2004 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21211_Follistim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21211ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021211s000_FollistimTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2016 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
| 11/15/2016 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 11/09/2015 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 08/22/2011 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021211s011ltr.pdf | |
| 06/28/2010 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021211s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021211s007ltr.pdf | |
| 02/11/2005 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21211s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21211s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/22/2011 | SUPPL-11 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf | |
| 06/28/2010 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021211s007lbl.pdf | |
| 02/11/2005 | SUPPL-2 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21211s002lbl.pdf |
| 03/23/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21211_Follistim_lbl.pdf |
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