Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087355
Company: FOUGERA PHARMS INC

Products on ANDA 087355

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROGLYCERIN	NITROGLYCERIN	2%	OINTMENT;TRANSDERMAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087355

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1981	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2020	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
10/05/2005	SUPPL-26	Labeling		Label is not available on this site.
08/06/2004	SUPPL-25	Labeling		Label is not available on this site.
08/31/1999	SUPPL-23	Labeling		Label is not available on this site.
06/09/1999	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/26/1999	SUPPL-19	Labeling		Label is not available on this site.
04/26/1999	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
04/26/1999	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
03/07/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/05/1993	SUPPL-15	Labeling		Label is not available on this site.
01/31/1992	SUPPL-14	Labeling		Label is not available on this site.
09/30/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/22/1991	SUPPL-12	Labeling		Label is not available on this site.
03/20/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/31/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/31/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/15/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/01/1984	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/01/1984	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087355

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