Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203543
Company: SOFIE

Products on ANDA 203543

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMMONIA N 13	AMMONIA N-13	3.75mCi-260mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203543

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2012	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
05/12/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203543

AMMONIA N 13

INJECTABLE;INTRAVENOUS; 3.75mCi-260mCi/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	3.75mCi-260mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215083	METHODIST
AMMONIA N 13	AMMONIA N-13	3.75mCi-260mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204515	NCM USA BRONX LLC
AMMONIA N 13	AMMONIA N-13	3.75mCi-260mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204547	PRECISION NUCLEAR
AMMONIA N 13	AMMONIA N-13	3.75mCi-260mCi/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203543	SOFIE