Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204515
Company: NCM USA BRONX LLC

Products on ANDA 204515

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204515

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/04/2015	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204515

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