Drugs@FDA: FDA Approved Drug Products

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

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

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