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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020519
Company: ALVOGEN

Products on NDA 020519

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CICLOPIROX	CICLOPIROX	0.77% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020519

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/1997	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
06/28/2013	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf
03/26/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20519slr005_loprox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20519slr005ltr.pdf
07/01/1999	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/10/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/25/2000	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/25/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020519

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2013	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf
03/26/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20519slr005_loprox_lbl.pdf

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