Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022114
Company: POWDER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINGO LIDOCAINE HYDROCHLORIDE 0.5MG SYSTEM;INTRADERMAL Prescription 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
08/16/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022114s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022114_zingo_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022114s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022114Orig1s004ltr.pdf
09/29/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/24/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/08/2009 SUPPL-1 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022114s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022114s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/02/2018 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022114s004lbl.pdf
01/08/2009 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022114s001lbl.pdf
08/16/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022114lbl.pdf

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