Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020010
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOTRISONE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/08/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form and Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20010_Lotrisone.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/11/2009 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020010s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020010s021ltr.pdf | |
12/18/2008 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020010s020ltr.pdf |
01/25/2008 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020010s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020010s015ltr.pdf | |
04/24/2006 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020010s011LTR.pdf |
03/27/2003 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20010slr005_lotrisone_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20010slr005ltr.pdf | |
12/17/2002 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20010slr003_Lotrisone_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20010slr003ltr.pdf | |
04/04/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/10/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/11/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020010s021lbl.pdf | |
01/25/2008 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020010s015lbl.pdf | |
03/27/2003 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20010slr005_lotrisone_lbl.pdf | |
12/17/2002 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20010slr003_Lotrisone_lbl.pdf | |
12/08/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20010lbl.pdf |