Drugs@FDA: FDA-Approved Drugs
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GASTROGRAFIN | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | SOLUTION;ORAL, RECTAL | Prescription | AA | Yes | 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 |
---|---|---|---|---|---|---|---|
01/17/1958 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
08/29/2005 | SUPPL-32 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011245s032ltr.pdf |
12/15/2000 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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08/05/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
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05/19/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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03/05/1991 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/28/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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09/14/1983 | SUPPL-23 | Labeling |
Label is not available on this site. |
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08/03/1983 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/02/1983 | SUPPL-21 | Labeling |
Label is not available on this site. |
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09/14/1983 | SUPPL-20 | Efficacy |
Label is not available on this site. |
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09/13/1979 | SUPPL-19 | Labeling |
Label is not available on this site. |
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12/28/1978 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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02/27/1978 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/16/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/25/1975 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/08/1976 | SUPPL-12 | Labeling |
Label is not available on this site. |
GASTROGRAFIN
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 |