Drugs@FDA: FDA Approved Drug Products

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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 Label (PDF)
Letter (PDF)
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 Letter (PDF)

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 Letter (PDF)

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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