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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021134
Company: VIATRIS

Products on NDA 021134

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021134

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.html

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

Labels for NDA 021134

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

Therapeutic Equivalents for NDA 021134

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 SPECLT
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 RESEARCH
NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET;SUBLINGUAL	Prescription	No	AB	218583	VIWIT PHARM
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 SPECLT
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 RESEARCH
NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET;SUBLINGUAL	Prescription	No	AB	218583	VIWIT PHARM
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 SPECLT
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 RESEARCH
NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET;SUBLINGUAL	Prescription	No	AB	218583	VIWIT PHARM
NITROSTAT	NITROGLYCERIN	0.6MG	TABLET;SUBLINGUAL	Prescription	Yes	AB	021134	VIATRIS

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