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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020010
Company: MERCK SHARP DOHME

Products on NDA 020010

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DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020010

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.

Labels for NDA 020010

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

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