Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218138
Company: PAI HOLDINGS PHARM

Products on ANDA 218138

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218138

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218138

LIDOCAINE HYDROCHLORIDE VISCOUS

SOLUTION;ORAL; 2%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	216780	RUBICON
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	087872	WOCKHARDT BIO AG
LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	040708	CHARTWELL MOLECULAR
LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	218138	PAI HOLDINGS PHARM
LIDOCAINE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	088802	HIKMA