Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021359
Company: ABBVIE

• Summary Review

Products on NDA 021359

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RECTIV	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021359

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2011	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021359s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359_rectiv_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359Orig1s000SumR.pdf

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021359Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021359Orig1s005ltr.pdf

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

Therapeutic Equivalents for NDA 021359

RECTIV

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	216103	COSETTE
NITROGLYCERIN	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	No	AB	216452	ENCUBE
NITROGLYCERIN	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	No	AB	218756	SOLARIS PHARMA CORP
NITROGLYCERIN	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	No	AB	212222	TP ANDA HOLDINGS
RECTIV	NITROGLYCERIN	0.4%	OINTMENT;INTRA-ANAL	Prescription	Yes	AB	021359	ABBVIE