Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 203082
Company: EUGIA PHARMA

Products on ANDA 203082

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	AP	No	No
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203082

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2013	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
10/29/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203082

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

INJECTABLE;INJECTION; 1%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	215132	AFAXYS
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	214336	ASPIRO
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	214339	ASPIRO
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	208474	B BRAUN MEDICAL INC
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	207182	EUGIA PHARMA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	080404	FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	083158	HOSPIRA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	088329	HOSPIRA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	212821	HUONS
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	083173	INTL MEDICATION
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	214267	SINTETICA SA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	208017	SPECTRA MDCL DEVICES
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	080407	WEST-WARD PHARMS INT
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	088586	FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	088299	HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	203040	EUGIA PHARMA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	203082	EUGIA PHARMA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	080408	HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	084625	WEST-WARD PHARMS INT
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	040302	HOSPIRA
XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	Yes	AP	006488	FRESENIUS KABI USA

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	214339	ASPIRO
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	207182	EUGIA PHARMA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	080404	FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	040078	HOSPIRA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	083158	HOSPIRA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	088294	HOSPIRA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	083173	INTL MEDICATION
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	214267	SINTETICA SA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	080407	WEST-WARD PHARMS INT
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	088327	HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	203040	EUGIA PHARMA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	203082	EUGIA PHARMA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	017584	FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	084625	WEST-WARD PHARMS INT
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	040302	HOSPIRA
XYLOCAINE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	Yes	AP	006488	FRESENIUS KABI USA