Drugs@FDA: FDA-Approved Drugs
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 | 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 |
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 |