Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204457
Company: MIDWEST MEDCL

Products on ANDA 204457

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204457

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2015	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204457

AMMONIA N 13

INJECTABLE;INTRAVENOUS; 30mCi-300mCi/8ML (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	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203779	3D IMAGING DRUG
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203783	BRIGHAM WOMENS HOSP
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203700	CARDINAL HLTH 414
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	022119	FEINSTEIN
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207025	GEN HOSP
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204514	JOHNS HOPKINS UNIV
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203938	KREITCHMAN PET CTR
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203321	MCPRF
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204457	MIDWEST MEDCL
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204535	MIPS CRF
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204455	NUKEMED
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204465	SOFIE
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203812	UCLA BIOMEDICAL
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204496	UCSF RODIOPHARM
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	209507	UNIV TX SW MEDCTR
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211740	UNIV WISCONSIN
AMMONIA N 13	AMMONIA N-13	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204506	WA UNIV SCH MED