Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020612
Company: TEIKOKU PHARMA USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDODERM LIDOCAINE 5% PATCH;TOPICAL Prescription AB 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
03/19/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20612lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20612ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20612.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020612s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020612Orig1s014ltr.pdf
03/17/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/07/2015 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020612s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020612Orig1s012ltr.pdf
04/13/2010 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020612s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020612s011ltr.pdf
04/27/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020612s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020612s008LTR.pdf
05/05/2005 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020612s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020612s007ltr.pdf
07/02/2002 SUPPL-3 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020612_S003_Lidoderm Patch_APPROVAL PACKAGE.pdf
05/26/1999 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020612_S002_Lidoderm Patch_APPROVAL PACKAGE.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/02/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020612s014lbl.pdf
01/07/2015 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020612s012lbl.pdf
01/07/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020612s012lbl.pdf
04/13/2010 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020612s011lbl.pdf
04/27/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020612s008lbl.pdf
05/05/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020612s007lbl.pdf
03/19/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20612lbl.pdf

LIDODERM

PATCH;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE LIDOCAINE 5% PATCH;TOPICAL Prescription No AB 200675 ACTAVIS LABS UT INC
LIDOCAINE LIDOCAINE 5% PATCH;TOPICAL Prescription No AB 206463 AMNEAL
LIDOCAINE LIDOCAINE 5% PATCH;TOPICAL Prescription No AB 202346 MYLAN TECHNOLOGIES
LIDOCAINE LIDOCAINE 5% PATCH;TOPICAL Prescription No AB 209190 RHODES PHARMS
LIDODERM LIDOCAINE 5% PATCH;TOPICAL Prescription Yes AB 020612 TEIKOKU PHARMA USA

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