Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040710
Company: LANNETT CO INC

Products on ANDA 040710

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040710

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040710

LIDOCAINE HYDROCHLORIDE

SOLUTION;TOPICAL; 4%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LARYNG-O-JET KIT	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	086364	INTL MEDICATION
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	088803	HIKMA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	040710	LANNETT CO INC
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	216250	NOVITIUM PHARMA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	204494	PAI HOLDINGS PHARM
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	218182	TARO
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	087881	WOCKHARDT BIO AG