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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021022
Company: VALEANT BERMUDA

Products on NDA 021022

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENLAC	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021022

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/1999	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Patient Package Insert (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022LBLB.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-022_Penlac.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2004	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21022s004ltr.pdf
12/22/2003	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr003_penlac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr003ltr.pdf
06/09/2003	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr002ltr.pdf
02/09/2001	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 021022

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2004	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf
12/22/2003	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr003_penlac_lbl.pdf
06/09/2003	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer.pdf
12/17/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf

Therapeutic Equivalents for NDA 021022

PENLAC

SOLUTION;TOPICAL; 8%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078172	ACELLA
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078270	AKORN
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078046	CHARTWELL RX
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078233	COSETTE
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	077623	PADAGIS US
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078124	RISING
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078144	TARO PHARM INDS
PENLAC	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	Yes	AT	021022	VALEANT BERMUDA

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