Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021359
Company: ABBVIE

• Summary Review

Products on NDA 21359

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RECTIV	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Discontinued	None	Yes	No

Labels for NDA 021359

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021359Orig1s005lbl.pdf
06/21/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf