An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Yes
NITRO-DUR	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	Yes
NITRO-DUR	NITROGLYCERIN	0.3MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	Yes
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	Yes
NITRO-DUR	NITROGLYCERIN	0.8MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	Yes

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.cfm
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.cfm
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

Top