Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200675
Company: ACTAVIS LABS UT INC

Products on ANDA 200675

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE	LIDOCAINE	5%	PATCH;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200675

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2012	ORIG-1	Approval	Not Applicable		Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200675Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200675Orig1s000Approv.pdf

Therapeutic Equivalents for ANDA 200675

LIDOCAINE

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