Drugs@FDA: FDA-Approved Drugs
Company: ORGANON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELOCON | MOMETASONE FUROATE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/30/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/21/2018 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019796s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf | |
03/28/2013 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019796s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019796Orig1s026ltr.pdf | |
09/09/2005 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019796s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019796s020ltr.pdf | |
07/17/2002 | SUPPL-15 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19796slr008,se5-015ltr.pdf | |
07/13/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/07/2000 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/14/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/28/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/05/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/17/2002 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19796slr008,se5-015ltr.pdf | |
04/16/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/25/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/1992 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/25/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/13/1989 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/21/2018 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019796s029lbl.pdf | |
03/28/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019796s026lbl.pdf | |
09/09/2005 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019796s020lbl.pdf | |
07/17/2002 | SUPPL-15 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf | |
07/17/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19796s8s15lbl.pdf |