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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088803
Company: HIKMA

Products on ANDA 088803

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/1985	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
08/20/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
06/30/2008	SUPPL-13	Labeling		Label is not available on this site.
03/27/2000	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/27/2000	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/28/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/18/1991	SUPPL-7	Labeling		Label is not available on this site.
03/04/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/31/1989	SUPPL-5	Labeling		Label is not available on this site.
09/27/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/27/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/01/1988	SUPPL-2	Bioequivalence		Label is not available on this site.
10/17/1988	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 088803

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	087881	PHARMOBEDIENT
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	218182	SUN PHARMA CANADA
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION;TOPICAL	Prescription	No	AT	218411	THE J MOLNER

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