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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022114
Company: POWDER PHARMS

Products on NDA 022114

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022114

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

Labels for NDA 022114

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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