اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CYSTOGRAFIN از شرکت BRACCO
New Drug Application (NDA): 010040
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYSTOGRAFIN | DIATRIZOATE MEGLUMINE | 30% | SOLUTION;URETHRAL | Prescription |
None |
Yes | No |
CYSTOGRAFIN DILUTE | DIATRIZOATE MEGLUMINE | 18% | SOLUTION;URETHRAL | Prescription |
None |
Yes | No |
DIATRIZOATE MEGLUMINE | DIATRIZOATE MEGLUMINE | 76% | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
RENO-30 | DIATRIZOATE MEGLUMINE | 30% | SOLUTION;URETERAL | Discontinued |
None |
No | No |
RENO-60 | DIATRIZOATE MEGLUMINE | 60% | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
RENO-DIP | DIATRIZOATE MEGLUMINE | 30% | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
RENOGRAFIN-60 | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 52%;8% | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
RENOGRAFIN-76 | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
RENOVIST | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 34.3%;35% | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
RENOVIST II | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 28.5%;29.1% | INJECTABLE;INJECTION | Discontinued |
None |
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 |
---|---|---|---|---|---|---|---|
08/02/1955 | ORIG-1 | Approval |
Type 2 New Active Ingredient and Type 4 New Combination |
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 |
---|---|---|---|---|---|
07/06/2015 | SUPPL-171 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010040s171lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010040Orig1s171ltr.pdf |
||
10/23/2002 | SUPPL-168 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10040slr168ltr.pdf |
|
06/29/2000 | SUPPL-167 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/09/1994 | SUPPL-166 | Labeling |
Label is not available on this site. |
||
09/25/2003 | SUPPL-163 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10040spd163ltr.pdf |
|
07/07/1989 | SUPPL-162 | Labeling |
Label is not available on this site. |
||
06/08/1987 | SUPPL-160 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/25/1985 | SUPPL-159 | Labeling |
Label is not available on this site. |
||
07/23/1985 | SUPPL-158 | Labeling |
Label is not available on this site. |
||
07/23/1985 | SUPPL-157 | Labeling |
Label is not available on this site. |
||
06/06/1985 | SUPPL-156 | Labeling |
Label is not available on this site. |
||
06/05/1985 | SUPPL-155 | Labeling |
Label is not available on this site. |
||
06/06/1985 | SUPPL-154 | Labeling |
Label is not available on this site. |
||
07/23/1985 | SUPPL-153 | Labeling |
Label is not available on this site. |
||
07/23/1985 | SUPPL-152 | Labeling |
Label is not available on this site. |
||
06/06/1985 | SUPPL-151 | Labeling |
Label is not available on this site. |
||
07/23/1985 | SUPPL-150 | Labeling |
Label is not available on this site. |
||
06/12/1985 | SUPPL-149 | Labeling |
Label is not available on this site. |
||
06/12/1985 | SUPPL-148 | Labeling |
Label is not available on this site. |
||
06/06/1985 | SUPPL-147 | Labeling |
Label is not available on this site. |
||
06/12/1985 | SUPPL-146 | Labeling |
Label is not available on this site. |
||
01/28/1985 | SUPPL-145 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/23/1985 | SUPPL-144 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/1984 | SUPPL-143 | Efficacy |
Label is not available on this site. |
||
05/23/1985 | SUPPL-142 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/02/1983 | SUPPL-140 | Labeling |
Label is not available on this site. |
||
01/06/1984 | SUPPL-139 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/14/1985 | SUPPL-138 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/09/1982 | SUPPL-137 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/24/1982 | SUPPL-135 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/05/1991 | SUPPL-134 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
03/31/1982 | SUPPL-122 | Labeling |
Label is not available on this site. |
||
09/27/1982 | SUPPL-121 | Efficacy |
Label is not available on this site. |
||
07/01/1981 | SUPPL-120 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/01/1980 | SUPPL-118 | Labeling |
Label is not available on this site. |
||
06/04/1980 | SUPPL-117 | Labeling |
Label is not available on this site. |
||
07/01/1980 | SUPPL-116 | Labeling |
Label is not available on this site. |
||
06/20/1980 | SUPPL-115 | Labeling |
Label is not available on this site. |
||
04/14/1980 | SUPPL-114 | Labeling |
Label is not available on this site. |
||
06/04/1980 | SUPPL-113 | Labeling |
Label is not available on this site. |
||
06/30/1982 | SUPPL-111 | Labeling |
Label is not available on this site. |
||
03/14/1980 | SUPPL-110 | Labeling |
Label is not available on this site. |
||
01/26/1983 | SUPPL-109 | Labeling |
Label is not available on this site. |
||
08/03/1979 | SUPPL-108 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/10/1983 | SUPPL-107 | Efficacy |
Label is not available on this site. |
||
06/30/1982 | SUPPL-105 | Labeling |
Label is not available on this site. |
||
06/30/1980 | SUPPL-103 | Labeling |
Label is not available on this site. |
||
06/08/1979 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
06/08/1979 | SUPPL-101 | Labeling |
Label is not available on this site. |
||
06/08/1979 | SUPPL-100 | Labeling |
Label is not available on this site. |
||
01/24/1980 | SUPPL-99 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/12/1979 | SUPPL-98 | Labeling |
Label is not available on this site. |
||
10/12/1979 | SUPPL-97 | Labeling |
Label is not available on this site. |
||
09/13/1979 | SUPPL-96 | Labeling |
Label is not available on this site. |
||
03/19/1980 | SUPPL-95 | Labeling |
Label is not available on this site. |
||
09/13/1979 | SUPPL-94 | Labeling |
Label is not available on this site. |
||
06/26/1979 | SUPPL-93 | Labeling |
Label is not available on this site. |
||
02/16/1979 | SUPPL-92 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/28/1978 | SUPPL-91 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
02/23/1978 | SUPPL-89 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/15/1978 | SUPPL-88 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/14/1978 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
11/01/1977 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
10/21/1977 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
03/30/1979 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/11/1977 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
01/11/1977 | SUPPL-81 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/11/1977 | SUPPL-80 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/06/1976 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
08/22/1977 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
12/14/1976 | SUPPL-77 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/02/1976 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
01/31/1978 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
09/13/1976 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
09/10/1976 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
09/10/1976 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
09/06/1976 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
09/13/1976 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
09/13/1976 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
09/09/1976 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
09/10/1976 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
05/26/1976 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/16/1976 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
05/06/1976 | SUPPL-64 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/06/1976 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
05/05/1976 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
05/05/1976 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
05/05/1976 | SUPPL-59 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/06/1976 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
05/06/1976 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
09/24/1975 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/30/1975 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
09/30/1975 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
05/27/1975 | SUPPL-53 | Unspecified |
Label is not available on this site. |
||
06/17/1977 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/06/2015 | SUPPL-171 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010040s171lbl.pdf |
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