Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203543
Company: SOFIE
Company: SOFIE
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 |
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. |
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 |