Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216103
Company: COSETTE

Products on ANDA 216103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROGLYCERIN	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216103

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216103Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 216103

NITROGLYCERIN

OINTMENT;INTRA-ANAL; 0.4%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITROGLYCERIN	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	No	AB	212222	ACRUX DDS
NITROGLYCERIN	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	No	AB	216103	COSETTE
NITROGLYCERIN	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	No	AB	216452	ENCUBE
RECTIV	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	Yes	AB	021359	ABBVIE