Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019543
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ELOCON | MOMETASONE FUROATE | 0.1% | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 04/30/1987 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019543s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf | |
| 08/05/2016 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2013 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019543s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019543Orig1s024ltr.pdf | |
| 12/15/2002 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543slr014_Elocon_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19543slr014ltr.pdf | |
| 07/17/2002 | SUPPL-13 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19543slr011,se5-013ltr.pdf | |
| 02/27/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19543slr011,se5-013ltr.pdf | |
| 01/20/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1998 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/28/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-3 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 10/29/1987 | SUPPL-1 | Manufacturing (CMC) |
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-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019543s028lbl.pdf | |
| 03/28/2013 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019543s024lbl.pdf | |
| 12/15/2002 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543slr014_Elocon_lbl.pdf | |
| 07/17/2002 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf | |
| 07/17/2002 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf |