Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019129
Company: AUROBINDO PHARMA USA

Products on NDA 19129

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAXZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MAXZIDE-25	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 019129

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-56	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019129s056lbl.pdf
03/20/2011	SUPPL-43	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019129s043lbl.pdf