Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087388
Company: LIEBEL-FLARSHEIM
Company: LIEBEL-FLARSHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MD-GASTROVIEW | 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 |
---|---|---|---|---|---|---|---|
09/02/1981 | 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 |
---|---|---|---|---|---|
09/28/2009 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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09/28/2009 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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06/30/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
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04/26/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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07/13/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/13/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
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02/27/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/21/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/21/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
MD-GASTROVIEW
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 |