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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040282
Company: RISING

Products on ANDA 040282

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 040282

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/1999	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40282ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40282_Digoxin.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2020	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
01/28/2019	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
11/02/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/03/2014	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040282Orig1s013ltr.pdf
06/12/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/18/2001	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/18/2001	SUPPL-4	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
02/07/2001	SUPPL-3	Labeling		Label is not available on this site.
10/31/2000	SUPPL-2	Labeling		Label is not available on this site.
02/07/2001	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for ANDA 040282

DIGOXIN

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	078556	IMPAX LABS
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	CONCORDIA

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	078556	IMPAX LABS
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	CONCORDIA

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