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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019625
Company: ORGANON

Products on NDA 019625

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ELOCON	MOMETASONE FUROATE	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	No	No
ELOCON	MOMETASONE FUROATE	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019625

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/1987	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-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019625s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018827Orig1s049,019543Orig1s028,019625Orig1s026,019796Orig1s029ltr.pdf
04/19/2013	SUPPL-24	Efficacy-Manufacturing Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019625s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019625Orig1s024ltr.pdf
07/17/2002	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19625slr012,se5-013ltr.pdf
07/17/2002	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19625slr012,se5-013ltr.pdf
04/13/2000	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1998	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/28/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/05/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/21/1998	SUPPL-7	Manufacturing (CMC)-Control		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.

Labels for NDA 019625

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2018	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019625s026lbl.pdf
04/19/2013	SUPPL-24	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019625s024lbl.pdf
07/17/2002	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf
07/17/2002	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19625s12s13lbl.pdf

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