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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020145
Company: USPHARMA

Products on NDA 020145

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITRO-DUR	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No
NITRO-DUR	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No
NITRO-DUR	NITROGLYCERIN	0.3MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No
NITRO-DUR	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	Yes
NITRO-DUR	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No
NITRO-DUR	NITROGLYCERIN	0.8MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020145

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/1985	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/08/2016	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
10/02/2014	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020145s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020145Orig1s027ltr.pdf
04/05/2005	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20145s021ltr.pdf
10/18/2002	SUPPL-16	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20145scs016ltr.pdf
06/24/2004	SUPPL-15	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20145slr015ltr.pdf
03/07/2002	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
05/31/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
08/23/2000	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/17/1999	SUPPL-11	Labeling		Label is not available on this site.
06/04/1997	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
02/07/1996	SUPPL-9	Labeling		Label is not available on this site.
11/08/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/23/1995	SUPPL-7	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020145s007_nitro-dur_toc.html
04/14/1995	SUPPL-6	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020145s006_nitro-dur_toc.html
04/04/1995	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/04/1995	SUPPL-1	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 020145

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/02/2014	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020145s027lbl.pdf

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