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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020612
Company: TEIKOKU PHARMA USA

Products on NDA 020612

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDODERM	LIDOCAINE	5%	PATCH;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020612

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

Labels for NDA 020612

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

Therapeutic Equivalents for NDA 020612

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	209190	IBSA
LIDOCAINE	LIDOCAINE	5%	PATCH;TOPICAL	Prescription	No	AB	202346	MYLAN TECHNOLOGIES
LIDOCAINE	LIDOCAINE	5%	PATCH;TOPICAL	Prescription	No	AB	205882	NAL PHARM
LIDODERM	LIDOCAINE	5%	PATCH;TOPICAL	Prescription	Yes	AB	020612	TEIKOKU PHARMA USA

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