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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019555
Company: ORGANON

Products on NDA 019555

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AF	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019555

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/1987	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
05/01/2019	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019555s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018741Orig1s040;019555Orig1s035;019716Orig1s033ltr.pdf
03/28/2018	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019555s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf
08/13/2014	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019555s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf
08/28/2006	SUPPL-26	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019555s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019555s026ltr.pdf
04/04/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/2001	SUPPL-16	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-555S008_Diprosone.cfm
08/14/2000	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/14/1999	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1998	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/07/1998	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
07/31/1998	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/1998	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/1995	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/2001	SUPPL-8	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-555S008_Diprosone.cfm
06/29/1990	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
08/01/1990	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/24/1989	SUPPL-5	Labeling		Label is not available on this site.
11/08/1988	SUPPL-4	Labeling		Label is not available on this site.
10/29/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

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

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