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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214269
Company: SINTETICA US

Products on ANDA 214269

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214269

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214269

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION; 4%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE;INJECTION	Prescription	No	AP	214269	SINTETICA US
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE;INJECTION	Prescription	No	AP	017584	FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE;INJECTION	Prescription	No	AP	088295	HOSPIRA

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