Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210524
Company: IONETIX

Products on ANDA 210524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMMONIA N 13	AMMONIA N-13	22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/2020	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 210524

AMMONIA N 13

INJECTABLE;INTRAVENOUS; 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMMONIA N 13	AMMONIA N-13	22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	210524	IONETIX