Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204514
Company: JOHNS HOPKINS UNIV
Company: JOHNS HOPKINS UNIV
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 |
---|---|---|---|---|---|---|---|
08/19/2014 | 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 HLTH 414 |
AMMONIA N 13 | AMMONIA N-13 | 30mCi-300mCi/8ML (3.75-37.5mCi/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204465 | DECATUR |
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 | 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 |