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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217221
Company: DIFGEN PHARMS

Products on ANDA 217221

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE	LIDOCAINE	1.8%	PATCH;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217221

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217221

LIDOCAINE

PATCH;TOPICAL; 1.8%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE	LIDOCAINE	1.8%	PATCH;TOPICAL	Prescription	No	AB	217221	DIFGEN PHARMS
ZTLIDO	LIDOCAINE	1.8%	PATCH;TOPICAL	Prescription	Yes	AB	207962	SCILEX PHARMS

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