Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018827
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOTRISONE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 07/10/1984 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 06/14/2019 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018827s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018827Orig1s050ltr.pdf | |
| 05/21/2018 | SUPPL-49 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018827s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf | |
| 04/21/2014 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018827Orig1s046ltr.pdf | |
| 05/11/2009 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018827s042ltr.pdf | |
| 01/25/2008 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018827s038ltr.pdf | |
| 03/27/2003 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18827slr025ltr.pdf | |
| 01/10/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18827s22ltr.pdf | |
| 02/28/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1998 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/18/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1994 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-7 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf | |
| 08/01/1990 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1985 | 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 |
|---|---|---|---|---|---|
| 06/14/2019 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018827s050lbl.pdf | |
| 05/21/2018 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018827s049lbl.pdf | |
| 05/21/2018 | SUPPL-49 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018827s049lbl.pdf | |
| 04/21/2014 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf | |
| 05/11/2009 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf | |
| 01/25/2008 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf | |
| 03/27/2003 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf | |
| 10/03/2001 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf | |
| 10/03/2001 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf |