Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 212390
Company: MEDUNIK

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITISINONE	NITISINONE	2MG	CAPSULE;ORAL	Prescription	AB	No	No
NITISINONE	NITISINONE	5MG	CAPSULE;ORAL	Prescription	AB	No	No
NITISINONE	NITISINONE	10MG	CAPSULE;ORAL	Prescription	AB	No	No
NITISINONE	NITISINONE	20MG	CAPSULE;ORAL	Prescription	AB	No	No

Showing 1 to 4 of 4 entries

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
05/26/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Showing 1 to 1 of 1 entries

CAPSULE;ORAL; 2MG
TE Code = AB

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Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITISINONE	NITISINONE	2MG	CAPSULE;ORAL	Prescription	No	AB	216201	ETON
NITISINONE	NITISINONE	2MG	CAPSULE;ORAL	Prescription	No	AB	212390	MEDUNIK
NITISINONE	NITISINONE	2MG	CAPSULE;ORAL	Prescription	No	AB	211041	NOVITIUM PHARMA
ORFADIN	NITISINONE	2MG	CAPSULE;ORAL	Prescription	Yes	AB	021232	SWEDISH ORPHAN

Showing 1 to 4 of 4 entries

CAPSULE;ORAL; 5MG
TE Code = AB

CSV Excel Print

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITISINONE	NITISINONE	5MG	CAPSULE;ORAL	Prescription	No	AB	216201	ETON
NITISINONE	NITISINONE	5MG	CAPSULE;ORAL	Prescription	No	AB	212390	MEDUNIK
NITISINONE	NITISINONE	5MG	CAPSULE;ORAL	Prescription	No	AB	211041	NOVITIUM PHARMA
ORFADIN	NITISINONE	5MG	CAPSULE;ORAL	Prescription	Yes	AB	021232	SWEDISH ORPHAN

Showing 1 to 4 of 4 entries

CAPSULE;ORAL; 10MG
TE Code = AB

CSV Excel Print

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITISINONE	NITISINONE	10MG	CAPSULE;ORAL	Prescription	No	AB	216201	ETON
NITISINONE	NITISINONE	10MG	CAPSULE;ORAL	Prescription	No	AB	212390	MEDUNIK
NITISINONE	NITISINONE	10MG	CAPSULE;ORAL	Prescription	No	AB	211041	NOVITIUM PHARMA
ORFADIN	NITISINONE	10MG	CAPSULE;ORAL	Prescription	Yes	AB	021232	SWEDISH ORPHAN

Showing 1 to 4 of 4 entries

CAPSULE;ORAL; 20MG
TE Code = AB

CSV Excel Print

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITISINONE	NITISINONE	20MG	CAPSULE;ORAL	Prescription	No	AB	216201	ETON
NITISINONE	NITISINONE	20MG	CAPSULE;ORAL	Prescription	No	AB	212390	MEDUNIK
ORFADIN	NITISINONE	20MG	CAPSULE;ORAL	Prescription	Yes	AB	021232	SWEDISH ORPHAN

Showing 1 to 3 of 3 entries