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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021159
Company: BAUSCH

Products on NDA 021159

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOPROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021159

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021159lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21159ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21159_Loprox.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/07/2016	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/03/2015	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/08/2013	SUPPL-20	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021159s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021159Orig1s020ltr.pdf
12/06/2012	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021159s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021159Orig1s019ltr.pdf
06/12/2006	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021159s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021159s009LTR.pdf
02/26/2004	SUPPL-1	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21159scp001ltr.pdf

Labels for NDA 021159

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2013	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021159s020lbl.pdf
12/06/2012	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021159s019lbl.pdf
06/12/2006	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021159s009lbl.pdf
02/28/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021159lbl.pdf

Therapeutic Equivalents for NDA 021159

LOPROX

SHAMPOO;TOPICAL; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	090490	ACTAVIS MID ATLANTIC
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	090146	FOUGERA PHARMS
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	078594	PADAGIS US
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	090269	TARO
LOPROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	Yes	AT	021159	BAUSCH

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