Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019555
Company: ORGANON

Products on NDA 19555

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIPROLENE AF	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CREAM, AUGMENTED;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 019555

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2019	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019555s035lbl.pdf
03/28/2018	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019555s034lbl.pdf
08/13/2014	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019555s033lbl.pdf
08/28/2006	SUPPL-26	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019555s026lbl.pdf
10/03/2001	SUPPL-16	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf
10/03/2001	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf