Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022055
Company: AQUA PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALTABAX RETAPAMULIN 1% OINTMENT;TOPICAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/12/2007 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022055s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022055s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/28/2010 SUPPL-4 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022055s004ltr.pdf
08/01/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/21/2012 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022055s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022055Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022055s002lbl.pdf
09/28/2010 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf
09/28/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf
04/12/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022055lbl.pdf

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