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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019716
Company: ORGANON

Products on NDA 019716

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DIPROLENE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION, AUGMENTED;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019716

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/1988	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
05/01/2019	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019716s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018741Orig1s040;019555Orig1s035;019716Orig1s033ltr.pdf
03/28/2018	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019716s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf
08/13/2014	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf
08/28/2006	SUPPL-22	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s022ltr.pdf
04/24/2006	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s021LTR.pdf
05/11/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/2000	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/14/1999	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
07/31/1998	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/1998	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/25/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/07/2005	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019716s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019716s006ltr.pdf
07/01/1992	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/01/1990	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/24/1989	SUPPL-3	Labeling		Label is not available on this site.
04/06/1989	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 019716

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2019	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019716s033lbl.pdf
03/28/2018	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019716s032lbl.pdf
08/13/2014	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf
08/28/2006	SUPPL-22	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf
10/07/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019716s006lbl.pdf

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