Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210524
Company: IONETIX
Company: IONETIX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMMONIA N 13 | AMMONIA N-13 | 22.5mCi-225mCi/6ML (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 |
---|---|---|---|---|---|---|---|
12/21/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/31/2020 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
AMMONIA N 13
INJECTABLE;INTRAVENOUS; 22.5mCi-225mCi/6ML (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 | 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 210524 | IONETIX |