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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218235
Company: ENCUBE

Products on ANDA 218235

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROGLYCERIN	NITROGLYCERIN	2%	OINTMENT;TRANSDERMAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218235

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218235

NITROGLYCERIN

OINTMENT;TRANSDERMAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITROGLYCERIN	NITROGLYCERIN	2%	OINTMENT;TRANSDERMAL	Prescription	No	AB	218235	ENCUBE
NITROGLYCERIN	NITROGLYCERIN	2%	OINTMENT;TRANSDERMAL	Prescription	Yes	AB	087355	FOUGERA PHARMS INC

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