Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214201
Company: ANDA REPOSITORY
Company: ANDA REPOSITORY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | SOLUTION;ORAL, RECTAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
06/27/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
SOLUTION;ORAL, RECTAL; 66%;10%
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 214201 | ANDA REPOSITORY |
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 215049 | ANNORA PHARMA |
GASTROGRAFIN | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | SOLUTION;ORAL, RECTAL | Prescription | Yes | AA | 011245 | BRACCO |
MD-GASTROVIEW | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 087388 | LIEBEL-FLARSHEIM |