Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040433
Company: SENTISS

Products on ANDA 040433

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 040433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/040433Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2025	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.
03/25/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/10/2017	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040433

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