Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021134
Company: VIATRIS
Company: VIATRIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROSTAT | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | AB | Yes | No |
NITROSTAT | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | AB | Yes | No |
NITROSTAT | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/01/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21134lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21134ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21134_Nitrostat.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/24/2018 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021134s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021134Orig1s010ltr.pdf | |
01/31/2017 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021134s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021134Orig1s009ltr.pdf | |
08/29/2016 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021134s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021134Orig1s008ltr.pdf | |
03/07/2014 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021134s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021134Orig1s007ltr_corrected.pdf | |
07/21/2011 | SUPPL-5 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021134s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021134s005ltr.pdf | |
07/12/2010 | SUPPL-4 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021134s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021134s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/24/2018 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021134s010lbl.pdf | |
01/31/2017 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021134s009lbl.pdf | |
08/29/2016 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021134s008lbl.pdf | |
03/07/2014 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021134s007lbl.pdf | |
07/21/2011 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021134s005lbl.pdf | |
07/12/2010 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021134s004lbl.pdf | |
05/01/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21134lbl.pdf |
NITROSTAT
TABLET;SUBLINGUAL; 0.3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217879 | AUROBINDO PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 208191 | DR REDDYS |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 206391 | GLENMARK PHARMS SA |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217970 | MANKIND PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | NATCO |
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | No | AB | 209779 | RUBICON |
NITROSTAT | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | VIATRIS |
TABLET;SUBLINGUAL; 0.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217879 | AUROBINDO PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 208191 | DR REDDYS |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 206391 | GLENMARK PHARMS SA |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217970 | MANKIND PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | NATCO |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | No | AB | 209779 | RUBICON |
NITROSTAT | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | VIATRIS |
TABLET;SUBLINGUAL; 0.6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217879 | AUROBINDO PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 208191 | DR REDDYS |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 206391 | GLENMARK PHARMS SA |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 217970 | MANKIND PHARMA |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 211604 | NATCO |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | No | AB | 209779 | RUBICON |
NITROSTAT | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | Prescription | Yes | AB | 021134 | VIATRIS |