Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076320
Company: ENCUBE

Products on ANDA 076320

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076320

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/2003	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
11/28/2012	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/23/2009	SUPPL-12	Labeling		Label is not available on this site.
07/10/2007	SUPPL-10	Labeling		Label is not available on this site.
10/22/2007	SUPPL-8	Labeling		Label is not available on this site.
08/11/2004	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076320

LIDOCAINE AND PRILOCAINE

CREAM;TOPICAL; 2.5%;2.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	213923	ALEMBIC
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	076320	ENCUBE
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	076453	FOUGERA PHARMS
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	212482	PADAGIS US