Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086283
Company: INTL MEDICATION

Products on ANDA 086283

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086283

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/1979	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
09/19/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/17/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/25/1993	SUPPL-14	Labeling		Label is not available on this site.
12/17/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/08/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/10/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/05/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/16/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/16/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086283

LIDOCAINE HYDROCHLORIDE

JELLY;TOPICAL; 2%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYDO	LIDOCAINE HYDROCHLORIDE	2%	JELLY;TOPICAL	Prescription	No	AT	201094	SAGENT PHARMS INC
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	JELLY;TOPICAL	Prescription	No	AT	086283	INTL MEDICATION
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	JELLY;TOPICAL	Prescription	No	AT	040433	SENTISS