Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021134
Company: PFIZER PHARMS
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 203693 ACTAVIS LABS FL INC
NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription No AB 211604 ALVOGEN
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 207745 SIGMAPHARM LABS LLC
NITROSTAT NITROGLYCERIN 0.3MG TABLET;SUBLINGUAL Prescription Yes AB 021134 PFIZER PHARMS

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 203693 ACTAVIS LABS FL INC
NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription No AB 211604 ALVOGEN
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 207745 SIGMAPHARM LABS LLC
NITROSTAT NITROGLYCERIN 0.4MG TABLET;SUBLINGUAL Prescription Yes AB 021134 PFIZER PHARMS

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 203693 ACTAVIS LABS FL INC
NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET;SUBLINGUAL Prescription No AB 211604 ALVOGEN
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 207745 SIGMAPHARM LABS LLC
NITROSTAT NITROGLYCERIN 0.6MG TABLET;SUBLINGUAL Prescription Yes AB 021134 PFIZER PHARMS

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