Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017373
Company: ALVOGEN

Products on NDA 017373

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017373

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/1973	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
12/16/2005	SUPPL-38	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
09/26/2000	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
07/22/1996	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
11/16/1992	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
04/24/1992	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
03/12/1991	SUPPL-31	Labeling		Label is not available on this site.
02/13/1990	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/1989	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
02/10/1989	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
04/10/1985	SUPPL-27	Labeling		Label is not available on this site.
08/29/1984	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
09/07/1983	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
12/06/1983	SUPPL-24	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/21/1983	SUPPL-23	Labeling		Label is not available on this site.
11/19/1982	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/20/1981	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/10/1981	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
11/03/1981	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/1981	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/19/1981	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/19/1981	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/07/1980	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/23/1979	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/13/1979	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/29/1978	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/1978	SUPPL-10	Labeling		Label is not available on this site.
10/13/1978	SUPPL-9	Labeling		Label is not available on this site.
07/05/1978	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/14/1977	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
06/04/1977	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/04/1977	SUPPL-5	Labeling		Label is not available on this site.
01/23/1976	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for NDA 017373

FLUOCINONIDE

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	Yes	AB	017373	ALVOGEN
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	072933	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	074935	TARO