Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204496
Company: UCSF RODIOPHARM
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/28/2014 ORIG-1 Approval

Label is not available on this site.

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 HEALTH 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 204465 GLOBAL ISOTOPES LLC
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 SPECTRON MRC LLC
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 203933 UNIV TX MD ANDERSON
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204506 WA UNIV SCH MED

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