Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021043
Company: BAYER HEALTHCARE LLC

Products on NDA 021043

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RID MOUSSE	PIPERONYL BUTOXIDE; PYRETHRINS	4%;EQ 0.33% BASE	AEROSOL;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021043

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-043_RID.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2006	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021043s006LTR.pdf
12/20/2004	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21043s005ltr.pdf
10/25/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/27/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/22/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021043

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21043lbl.pdf