Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088802
Company: HIKMA

Products on ANDA 088802

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088802

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/1985	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
11/02/2018	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/17/2014	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/30/2008	SUPPL-20	Labeling		Label is not available on this site.
02/14/2002	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/29/1996	SUPPL-13	Labeling		Label is not available on this site.
06/30/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/01/1994	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/12/1991	SUPPL-10	Labeling		Label is not available on this site.
03/21/1991	SUPPL-9	Labeling		Label is not available on this site.
11/16/1990	SUPPL-8	Labeling		Label is not available on this site.
10/11/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/27/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/27/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/17/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088802

LIDOCAINE 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	219759	AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	087872	PHARMOBEDIENT
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	218676	QUAGEN
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION;ORAL	Prescription	No	AT	216780	RUBICON RESEARCH
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