Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020145
Company: USPHARMA
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 AB1 Yes Yes
NITRO-DUR NITROGLYCERIN 0.2MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB1 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 AB1 Yes Yes
NITRO-DUR NITROGLYCERIN 0.6MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB1 Yes Yes
NITRO-DUR NITROGLYCERIN 0.8MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes Yes
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.

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

NITRO-DUR

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINITRAN NITROGLYCERIN 0.1MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 089771 VALEANT PHARMS
NITRO-DUR NITROGLYCERIN 0.1MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020145 USPHARMA

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.2MG/HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINITRAN NITROGLYCERIN 0.2MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 089772 VALEANT PHARMS NORTH
NITRO-DUR NITROGLYCERIN 0.2MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020145 USPHARMA

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.4MG/HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINITRAN NITROGLYCERIN 0.4MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 089773 MEDICIS
NITRO-DUR NITROGLYCERIN 0.4MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020145 USPHARMA

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.6MG/HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINITRAN NITROGLYCERIN 0.6MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB1 089774 VALEANT PHARMS
NITRO-DUR NITROGLYCERIN 0.6MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB1 020145 USPHARMA

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