Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021717
Company: TARO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLIAGLIS LIDOCAINE; TETRACAINE 7%;7% CREAM;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
06/29/2006 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021717lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021717s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021717_tradename_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021717Orig1s011ltr.pdf
12/11/2018 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021717Orig1s010ltr.pdf
11/21/2017 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021717s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021717Orig1s009ltr.pdf
03/09/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/07/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021717s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021717Orig1s005ltr.pdf
06/28/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021717s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021717s002_ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/11/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s010lbl.pdf
12/11/2018 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s010lbl.pdf
11/02/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021717s011lbl.pdf
11/21/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021717s009lbl.pdf
11/21/2017 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021717s009lbl.pdf
11/07/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021717s005lbl.pdf
06/28/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021717s002lbl.pdf
06/29/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021717lbl.pdf

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