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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018751
Company: ALVOGEN

Products on NDA 018751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPECTAZOLE	ECONAZOLE NITRATE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018751

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/1982	ORIG-1	Approval	Type 1 - New Molecular Entity	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
01/21/2020	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018751s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018751Orig1s025ltr.pdf
09/07/2017	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf
03/28/2014	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018751Orig1s023ltr.pdf
07/11/2001	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
04/04/2001	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
03/20/2001	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/23/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/17/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/24/1995	SUPPL-11	Labeling		Label is not available on this site.
09/10/1992	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/09/1990	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
04/25/1990	SUPPL-6	Labeling		Label is not available on this site.
12/18/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/28/1985	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/08/1985	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/22/1985	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018751

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/21/2020	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018751s025lbl.pdf
09/07/2017	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf
03/28/2014	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf

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