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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018849
Company: ALVOGEN

Products on NDA 018849

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDEX	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018849

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/1984	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
02/28/2014	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018849Orig1s020ltr.pdf
12/16/2005	SUPPL-18	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,017373s038,018849s018ltr.pdf
09/27/2001	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/27/2000	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/22/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/01/1995	SUPPL-13	Labeling		Label is not available on this site.
11/16/1992	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
04/24/1992	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
03/14/1995	SUPPL-10	Labeling		Label is not available on this site.
02/13/1990	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/1989	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/19/1989	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/19/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/10/1989	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/29/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/13/1985	SUPPL-2	Labeling		Label is not available on this site.
04/09/1985	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

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