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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019259
Company: PFIZER

Products on NDA 019259

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLORONE E	DIFLORASONE DIACETATE	0.05%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019259

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/1985	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
10/25/2017	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019259s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017741Orig1s024,017994Orig1s026,019259Orig1s012,019260Orig1s009ltr.pdf
05/29/2003	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19259slr009_psorcon_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19259slr009ltr.pdf
01/21/1999	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/10/1997	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/17/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/25/1993	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/26/1986	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/14/1986	SUPPL-2	Labeling		Label is not available on this site.
03/12/1986	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 019259

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019259s012lbl.pdf
05/29/2003	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19259slr009_psorcon_lbl.pdf

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