Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213000
Company: NOVITIUM PHARMA

Products on ANDA 213000

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIGOXIN	DIGOXIN	0.05MG/ML	ELIXIR;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213000

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/04/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213000Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213000

DIGOXIN

ELIXIR;ORAL; 0.05MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIGOXIN	DIGOXIN	0.05MG/ML	ELIXIR;ORAL	Prescription	No	AA	215209	AMICI
DIGOXIN	DIGOXIN	0.05MG/ML	ELIXIR;ORAL	Prescription	Yes	AA	021648	HIKMA
DIGOXIN	DIGOXIN	0.05MG/ML	ELIXIR;ORAL	Prescription	No	AA	213000	NOVITIUM PHARMA