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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077002
Company: HIKMA INTL PHARMS

Products on ANDA 077002

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077002

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2020	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
10/07/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
10/07/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/12/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/12/2016	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
11/12/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/30/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/23/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077002

DIGOXIN

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

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

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