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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214982
Company: AUROBINDO PHARMA LTD

Products on ANDA 214982

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIGOXIN	DIGOXIN	0.0625MG	TABLET;ORAL	Prescription	AB	No	No
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	AB	No	No
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214982

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214982Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2024	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 214982

DIGOXIN

TABLET;ORAL; 0.0625MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIGOXIN	DIGOXIN	0.0625MG	TABLET;ORAL	Prescription	No	AB	214982	AUROBINDO PHARMA LTD
DIGOXIN	DIGOXIN	0.0625MG	TABLET;ORAL	Prescription	No	AB	215307	NOVITIUM PHARMA
LANOXIN	DIGOXIN	0.0625MG	TABLET;ORAL	Prescription	Yes	AB	020405	ADVANZ PHARMA

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	214982	AUROBINDO PHARMA LTD
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	077002	HIKMA INTL PHARMS
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	215307	NOVITIUM PHARMA
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	040282	RISING
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	076268	STEVENS J
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	076363	SUN PHARM INDS INC
LANOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	Yes	AB	020405	ADVANZ PHARMA

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	214982	AUROBINDO PHARMA LTD
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	077002	HIKMA INTL PHARMS
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	215307	NOVITIUM PHARMA
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	040282	RISING
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	076268	STEVENS J
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	076363	SUN PHARM INDS INC
LANOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	Yes	AB	020405	ADVANZ PHARMA

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