Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208191
Company: DR REDDYS

Products on ANDA 208191

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET;SUBLINGUAL	Prescription	AB	No	No
NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET;SUBLINGUAL	Prescription	AB	No	No
NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET;SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208191

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208191s001ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/06/2023	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/06/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208191

NITROGLYCERIN

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