Bracco
FDA Approved Drugs

Bracco

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued Unclassified
  • Total Records 107
  • Latest Approval Date Aug 01, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
107
View
Unclassified
1
View
Discontinued
62
View
RX
44
View
Company Overview

Company

Bracco

Country

Italy

Social Profiles

LinkedIn
Company Snapshot

Bracco

Via Caduti di Marcinelle 13, 20134 Milan

Italy

www.bracco.com/en info@bracco.com View on Map
FDA Approved Drug Records ( 107 records )
1989
29 Dec
RX Application: 19414

Drug Name

CARDIOGEN-82

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1989-12-29

19414 / 1

Active Ingredient

RUBIDIUM CHLORIDE RB-82

Application Number

19414

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1989-12-29

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 11620

Drug Name

CARDIOGRAFIN

Product Number

2

Dosage Form

-

Strength

85%

Approval Date

1982-01-01

11620 / 2

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

11620

Product Number

2

Dosage Form

-

Strength

85%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1990
19 Dec
Discontinued Application: 19928

Drug Name

CARDIOTEC

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1990-12-19

19928 / 1

Active Ingredient

TECHNETIUM TC-99M TEBOROXIME KIT

Application Number

19928

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1990-12-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17269

Drug Name

CHLORMERODRIN HG 197

Product Number

1

Dosage Form

-

Strength

0.6-1.4mCi/ML

Approval Date

1982-01-01

17269 / 1

Active Ingredient

CHLORMERODRIN HG-197

Application Number

17269

Product Number

1

Dosage Form

-

Strength

0.6-1.4mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
21 Jan
RX Application: 18963

Drug Name

CHOLETEC

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1987-01-21

18963 / 1

Active Ingredient

TECHNETIUM TC-99M MEBROFENIN KIT

Application Number

18963

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1987-01-21

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 9321

Drug Name

CHOLOGRAFIN MEGLUMINE

Product Number

3

Dosage Form

-

Strength

52%

Approval Date

1982-01-01

Active Ingredient

IODIPAMIDE MEGLUMINE

Application Number

9321

Product Number

3

Dosage Form

-

Strength

52%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9321

Drug Name

CHOLOGRAFIN MEGLUMINE

Product Number

7

Dosage Form

-

Strength

10.3%

Approval Date

1982-01-01

Active Ingredient

IODIPAMIDE MEGLUMINE

Application Number

9321

Product Number

7

Dosage Form

-

Strength

10.3%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9321

Drug Name

CHOLOGRAFIN SODIUM

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1982-01-01

Active Ingredient

IODIPAMIDE SODIUM

Application Number

9321

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18076

Drug Name

CHOLOVUE

Product Number

1

Dosage Form

-

Strength

40.3%

Approval Date

1982-01-01

18076 / 1

Active Ingredient

IODOXAMATE MEGLUMINE

Application Number

18076

Product Number

1

Dosage Form

-

Strength

40.3%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18077

Drug Name

CHOLOVUE

Product Number

1

Dosage Form

-

Strength

9.9%

Approval Date

1982-01-01

18077 / 1

Active Ingredient

IODOXAMATE MEGLUMINE

Application Number

18077

Product Number

1

Dosage Form

-

Strength

9.9%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13993

Drug Name

CHROMITOPE SODIUM

Product Number

1

Dosage Form

-

Strength

200uCi/ML

Approval Date

1982-01-01

13993 / 1

Active Ingredient

SODIUM CHROMATE CR-51

Application Number

13993

Product Number

1

Dosage Form

-

Strength

200uCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 13993

Drug Name

CHROMITOPE SODIUM

Product Number

2

Dosage Form

-

Strength

2mCi/VIAL

Approval Date

1982-01-01

13993 / 2

Active Ingredient

SODIUM CHROMATE CR-51

Application Number

13993

Product Number

2

Dosage Form

-

Strength

2mCi/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 10040

Drug Name

CYSTOGRAFIN

Product Number

18

Dosage Form

-

Strength

30%

Approval Date

1982-01-01

10040 / 18

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

10040

Product Number

18

Dosage Form

-

Strength

30%

Approval Date

1982-01-01

Regulatory Status

RX

1982
09 Nov
RX Application: 10040

Drug Name

CYSTOGRAFIN DILUTE

Product Number

22

Dosage Form

-

Strength

18%

Approval Date

1982-11-09

10040 / 22

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

10040

Product Number

22

Dosage Form

-

Strength

18%

Approval Date

1982-11-09

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 10040

Drug Name

DIATRIZOATE MEGLUMINE

Product Number

17

Dosage Form

-

Strength

76%

Approval Date

1982-01-01

10040 / 17

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

10040

Product Number

17

Dosage Form

-

Strength

76%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2017
03 Jan
Discontinued Application: 208036

Drug Name

E-Z-CAT DRY

Product Number

3

Dosage Form

-

Strength

40%

Approval Date

2017-01-03

208036 / 3

Active Ingredient

BARIUM SULFATE

Application Number

208036

Product Number

3

Dosage Form

-

Strength

40%

Approval Date

2017-01-03

Regulatory Status

Discontinued

2025
01 Aug
RX Application: 219840

Drug Name

E-Z-DISK

Product Number

1

Dosage Form

-

Strength

700MG

Approval Date

2025-08-01

219840 / 1

Active Ingredient

BARIUM SULFATE

Application Number

219840

Product Number

1

Dosage Form

-

Strength

700MG

Approval Date

2025-08-01

Regulatory Status

RX

2016
11 Jan
RX Application: 208036

Drug Name

E-Z-HD

Product Number

1

Dosage Form

-

Strength

98%

Approval Date

2016-01-11

208036 / 1

Active Ingredient

BARIUM SULFATE

Application Number

208036

Product Number

1

Dosage Form

-

Strength

98%

Approval Date

2016-01-11

Regulatory Status

RX

2017
07 Apr
RX Application: 208036

Drug Name

E-Z-PAQUE

Product Number

2

Dosage Form

-

Strength

96%

Approval Date

2017-04-07

208036 / 2

Active Ingredient

BARIUM SULFATE

Application Number

208036

Product Number

2

Dosage Form

-

Strength

96%

Approval Date

2017-04-07

Regulatory Status

RX

2020
29 May
RX Application: 208143

Drug Name

ENTERO VU 24%

Product Number

8

Dosage Form

-

Strength

24%

Approval Date

2020-05-29

208143 / 8

Active Ingredient

BARIUM SULFATE

Application Number

208143

Product Number

8

Dosage Form

-

Strength

24%

Approval Date

2020-05-29

Regulatory Status

RX

1982
01 Jan
RX Application: 11245

Drug Name

GASTROGRAFIN

Product Number

3

Dosage Form

-

Strength

66%;10%

Approval Date

1982-01-01

11245 / 3

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

11245

Product Number

3

Dosage Form

-

Strength

66%;10%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 15419

Drug Name

HIPPUTOPE

Product Number

2

Dosage Form

-

Strength

1-2mCi/VIAL

Approval Date

1982-01-01

15419 / 2

Active Ingredient

IODOHIPPURATE SODIUM I-131

Application Number

15419

Product Number

2

Dosage Form

-

Strength

1-2mCi/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10929

Drug Name

IODOTOPE

Product Number

1

Dosage Form

-

Strength

1-130mCi

Approval Date

1982-01-01

10929 / 1

Active Ingredient

SODIUM IODIDE I-131

Application Number

10929

Product Number

1

Dosage Form

-

Strength

1-130mCi

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10929

Drug Name

IODOTOPE

Product Number

2

Dosage Form

-

Strength

7-106mCi/BOT

Approval Date

1982-01-01

10929 / 2

Active Ingredient

SODIUM IODIDE I-131

Application Number

10929

Product Number

2

Dosage Form

-

Strength

7-106mCi/BOT

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10929

Drug Name

IODOTOPE

Product Number

3

Dosage Form

-

Strength

1-150mCi

Approval Date

1982-01-01

10929 / 3

Active Ingredient

SODIUM IODIDE I-131

Application Number

10929

Product Number

3

Dosage Form

-

Strength

1-150mCi

Approval Date

1982-01-01

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

1

Dosage Form

-

Strength

25GM IODINE/100ML (250MG IODINE/ML)

Approval Date

2024-11-27

216016 / 1

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

1

Dosage Form

-

Strength

25GM IODINE/100ML (250MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

2

Dosage Form

-

Strength

15GM IODINE/50ML (300MG IODINE/ML)

Approval Date

2024-11-27

216016 / 2

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

2

Dosage Form

-

Strength

15GM IODINE/50ML (300MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

3

Dosage Form

-

Strength

30GM IODINE/100ML (300MG IODINE/ML)

Approval Date

2024-11-27

216016 / 3

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

3

Dosage Form

-

Strength

30GM IODINE/100ML (300MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

4

Dosage Form

-

Strength

45GM IODINE/150ML (300MG IODINE/ML)

Approval Date

2024-11-27

216016 / 4

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

4

Dosage Form

-

Strength

45GM IODINE/150ML (300MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

5

Dosage Form

-

Strength

60GM IODINE/200ML (300MG IODINE/ML)

Approval Date

2024-11-27

216016 / 5

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

5

Dosage Form

-

Strength

60GM IODINE/200ML (300MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

6

Dosage Form

-

Strength

17.5GM IODINE/50ML (350MG IODINE/ML)

Approval Date

2024-11-27

216016 / 6

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

6

Dosage Form

-

Strength

17.5GM IODINE/50ML (350MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
RX Application: 216016

Drug Name

IOMERVU

Product Number

7

Dosage Form

-

Strength

35GM IODINE/100ML (350MG IODINE/ML)

Approval Date

2024-11-27

216016 / 7

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

7

Dosage Form

-

Strength

35GM IODINE/100ML (350MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

RX

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

8

Dosage Form

-

Strength

52.5GM IODINE/150ML (350MG IODINE/ML

Approval Date

2024-11-27

216016 / 8

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

8

Dosage Form

-

Strength

52.5GM IODINE/150ML (350MG IODINE/ML

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
RX Application: 216016

Drug Name

IOMERVU

Product Number

9

Dosage Form

-

Strength

70GM IODINE/200ML (350MG IODINE/ML)

Approval Date

2024-11-27

216016 / 9

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

9

Dosage Form

-

Strength

70GM IODINE/200ML (350MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

RX

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

10

Dosage Form

-

Strength

20GM IODINE/50ML (400MG IODINE/ML)

Approval Date

2024-11-27

216016 / 10

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

10

Dosage Form

-

Strength

20GM IODINE/50ML (400MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
RX Application: 216016

Drug Name

IOMERVU

Product Number

11

Dosage Form

-

Strength

40GM IODINE/100ML (400MG IODINE/ML)

Approval Date

2024-11-27

216016 / 11

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

11

Dosage Form

-

Strength

40GM IODINE/100ML (400MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

RX

2024
27 Nov
Discontinued Application: 216016

Drug Name

IOMERVU

Product Number

12

Dosage Form

-

Strength

60GM IODINE/150ML (400MG IODINE/ML)

Approval Date

2024-11-27

216016 / 12

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

12

Dosage Form

-

Strength

60GM IODINE/150ML (400MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
RX Application: 216016

Drug Name

IOMERVU

Product Number

13

Dosage Form

-

Strength

80GM IODINE/200ML (400MG IODINE/ML)

Approval Date

2024-11-27

216016 / 13

Active Ingredient

IOMEPROL

Application Number

216016

Product Number

13

Dosage Form

-

Strength

80GM IODINE/200ML (400MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

RX

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

1

Dosage Form

-

Strength

25GM IODINE/100ML (250MG IODINE/ML)

Approval Date

2024-11-27

216017 / 1

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

1

Dosage Form

-

Strength

25GM IODINE/100ML (250MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

2

Dosage Form

-

Strength

15GM IODINE/50ML (300MG IODINE/ML)

Approval Date

2024-11-27

216017 / 2

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

2

Dosage Form

-

Strength

15GM IODINE/50ML (300MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

3

Dosage Form

-

Strength

30GM IODINE/100ML (300MG IODINE/ML)

Approval Date

2024-11-27

216017 / 3

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

3

Dosage Form

-

Strength

30GM IODINE/100ML (300MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

4

Dosage Form

-

Strength

45GM IODINE/150ML (300MG IODINE/ML)

Approval Date

2024-11-27

216017 / 4

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

4

Dosage Form

-

Strength

45GM IODINE/150ML (300MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

5

Dosage Form

-

Strength

60GM IODINE/200ML (300MG IODINE/ML)

Approval Date

2024-11-27

216017 / 5

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

5

Dosage Form

-

Strength

60GM IODINE/200ML (300MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

6

Dosage Form

-

Strength

17.5GM IODINE/50ML (350MG IODINE/ML)

Approval Date

2024-11-27

216017 / 6

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

6

Dosage Form

-

Strength

17.5GM IODINE/50ML (350MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
RX Application: 216017

Drug Name

IOMERVU

Product Number

7

Dosage Form

-

Strength

35GM IODINE/100ML (350MG IODINE/ML)

Approval Date

2024-11-27

216017 / 7

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

7

Dosage Form

-

Strength

35GM IODINE/100ML (350MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

RX

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

8

Dosage Form

-

Strength

52.5GM IODINE/150ML (350MG IODINE/ML)

Approval Date

2024-11-27

216017 / 8

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

8

Dosage Form

-

Strength

52.5GM IODINE/150ML (350MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
RX Application: 216017

Drug Name

IOMERVU

Product Number

9

Dosage Form

-

Strength

70GM IODINE/200ML (350MG IODINE/ML)

Approval Date

2024-11-27

216017 / 9

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

9

Dosage Form

-

Strength

70GM IODINE/200ML (350MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

RX

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

10

Dosage Form

-

Strength

20GM IODINE/50ML (400MG IODINE/ML)

Approval Date

2024-11-27

216017 / 10

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

10

Dosage Form

-

Strength

20GM IODINE/50ML (400MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
RX Application: 216017

Drug Name

IOMERVU

Product Number

11

Dosage Form

-

Strength

40GM IODINE/100ML (400MG IODINE/ML)

Approval Date

2024-11-27

216017 / 11

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

11

Dosage Form

-

Strength

40GM IODINE/100ML (400MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

RX

2024
27 Nov
Discontinued Application: 216017

Drug Name

IOMERVU

Product Number

12

Dosage Form

-

Strength

60GM IODINE/150ML (400MG IODINE/ML)

Approval Date

2024-11-27

216017 / 12

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

12

Dosage Form

-

Strength

60GM IODINE/150ML (400MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

Discontinued

2024
27 Nov
RX Application: 216017

Drug Name

IOMERVU

Product Number

13

Dosage Form

-

Strength

80GM IODINE/200ML (400MG IODINE/ML)

Approval Date

2024-11-27

216017 / 13

Active Ingredient

IOMEPROL

Application Number

216017

Product Number

13

Dosage Form

-

Strength

80GM IODINE/200ML (400MG IODINE/ML)

Approval Date

2024-11-27

Regulatory Status

RX

1986
21 Oct
Discontinued Application: 18735

Drug Name

ISOVUE-128

Product Number

5

Dosage Form

-

Strength

26%

Approval Date

1986-10-21

18735 / 5

Active Ingredient

IOPAMIDOL

Application Number

18735

Product Number

5

Dosage Form

-

Strength

26%

Approval Date

1986-10-21

Regulatory Status

Discontinued

1987
07 Jul
RX Application: 18735

Drug Name

ISOVUE-200

Product Number

6

Dosage Form

-

Strength

41%

Approval Date

1987-07-07

18735 / 6

Active Ingredient

IOPAMIDOL

Application Number

18735

Product Number

6

Dosage Form

-

Strength

41%

Approval Date

1987-07-07

Regulatory Status

RX

1994
12 Oct
Discontinued Application: 20327

Drug Name

ISOVUE-200

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1994-10-12

20327 / 1

Active Ingredient

IOPAMIDOL

Application Number

20327

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1994-10-12

Regulatory Status

Discontinued

1992
06 Jul
RX Application: 18735

Drug Name

ISOVUE-250

Product Number

7

Dosage Form

-

Strength

51%

Approval Date

1992-07-06

18735 / 7

Active Ingredient

IOPAMIDOL

Application Number

18735

Product Number

7

Dosage Form

-

Strength

51%

Approval Date

1992-07-06

Regulatory Status

RX

1994
12 Oct
Discontinued Application: 20327

Drug Name

ISOVUE-250

Product Number

2

Dosage Form

-

Strength

51%

Approval Date

1994-10-12

20327 / 2

Active Ingredient

IOPAMIDOL

Application Number

20327

Product Number

2

Dosage Form

-

Strength

51%

Approval Date

1994-10-12

Regulatory Status

Discontinued

1985
31 Dec
RX Application: 18735

Drug Name

ISOVUE-300

Product Number

2

Dosage Form

-

Strength

61%

Approval Date

1985-12-31

18735 / 2

Active Ingredient

IOPAMIDOL

Application Number

18735

Product Number

2

Dosage Form

-

Strength

61%

Approval Date

1985-12-31

Regulatory Status

RX

1994
12 Oct
RX Application: 20327

Drug Name

ISOVUE-300

Product Number

3

Dosage Form

-

Strength

61%

Approval Date

1994-10-12

20327 / 3

Active Ingredient

IOPAMIDOL

Application Number

20327

Product Number

3

Dosage Form

-

Strength

61%

Approval Date

1994-10-12

Regulatory Status

RX

1985
31 Dec
RX Application: 18735

Drug Name

ISOVUE-370

Product Number

3

Dosage Form

-

Strength

76%

Approval Date

1985-12-31

18735 / 3

Active Ingredient

IOPAMIDOL

Application Number

18735

Product Number

3

Dosage Form

-

Strength

76%

Approval Date

1985-12-31

Regulatory Status

RX

1994
12 Oct
RX Application: 20327

Drug Name

ISOVUE-370

Product Number

4

Dosage Form

-

Strength

76%

Approval Date

1994-10-12

20327 / 4

Active Ingredient

IOPAMIDOL

Application Number

20327

Product Number

4

Dosage Form

-

Strength

76%

Approval Date

1994-10-12

Regulatory Status

RX

1985
31 Dec
RX Application: 18735

Drug Name

ISOVUE-M 200

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1985-12-31

18735 / 1

Active Ingredient

IOPAMIDOL

Application Number

18735

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1985-12-31

Regulatory Status

RX

1985
31 Dec
RX Application: 18735

Drug Name

ISOVUE-M 300

Product Number

4

Dosage Form

-

Strength

61%

Approval Date

1985-12-31

18735 / 4

Active Ingredient

IOPAMIDOL

Application Number

18735

Product Number

4

Dosage Form

-

Strength

61%

Approval Date

1985-12-31

Regulatory Status

RX

1982
01 Jan
RX Application: 17697

Drug Name

KINEVAC

Product Number

1

Dosage Form

-

Strength

0.005MG/VIAL

Approval Date

1982-01-01

17697 / 1

Active Ingredient

SINCALIDE

Application Number

17697

Product Number

1

Dosage Form

-

Strength

0.005MG/VIAL

Approval Date

1982-01-01

Regulatory Status

RX

2017
01 Mar
RX Application: 208143

Drug Name

LIQUID E-Z-PAQUE

Product Number

3

Dosage Form

-

Strength

60%

Approval Date

2017-03-01

208143 / 3

Active Ingredient

BARIUM SULFATE

Application Number

208143

Product Number

3

Dosage Form

-

Strength

60%

Approval Date

2017-03-01

Regulatory Status

RX

2014
15 Oct
RX Application: 203684

Drug Name

LUMASON

Product Number

1

Dosage Form

-

Strength

60.7MG/25MG

Approval Date

2014-10-15

203684 / 1

Active Ingredient

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

Application Number

203684

Product Number

1

Dosage Form

-

Strength

60.7MG/25MG

Approval Date

2014-10-15

Regulatory Status

RX

1997
19 Dec
Discontinued Application: 20686

Drug Name

LUMENHANCE

Product Number

1

Dosage Form

-

Strength

3.49MG/GM

Approval Date

1997-12-19

20686 / 1

Active Ingredient

MANGANESE CHLORIDE TETRAHYDRATE

Application Number

20686

Product Number

1

Dosage Form

-

Strength

3.49MG/GM

Approval Date

1997-12-19

Regulatory Status

Discontinued

-
Unclassified Application: 17833

Drug Name

MACROTEC

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

-

17833 / 1

Active Ingredient

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

Application Number

17833

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 17339

Drug Name

MINITEC

Product Number

1

Dosage Form

-

Strength

0.22-2.22 CI/GENERATOR

Approval Date

1982-01-01

17339 / 1

Active Ingredient

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

Application Number

17339

Product Number

1

Dosage Form

-

Strength

0.22-2.22 CI/GENERATOR

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
23 Nov
RX Application: 21357

Drug Name

MULTIHANCE

Product Number

1

Dosage Form

-

Strength

2.645GM/5ML (529MG/ML)

Approval Date

2004-11-23

21357 / 1

Active Ingredient

GADOBENATE DIMEGLUMINE

Application Number

21357

Product Number

1

Dosage Form

-

Strength

2.645GM/5ML (529MG/ML)

Approval Date

2004-11-23

Regulatory Status

RX

2004
23 Nov
RX Application: 21357

Drug Name

MULTIHANCE

Product Number

2

Dosage Form

-

Strength

5.29GM/10ML (529MG/ML)

Approval Date

2004-11-23

21357 / 2

Active Ingredient

GADOBENATE DIMEGLUMINE

Application Number

21357

Product Number

2

Dosage Form

-

Strength

5.29GM/10ML (529MG/ML)

Approval Date

2004-11-23

Regulatory Status

RX

2004
23 Nov
RX Application: 21357

Drug Name

MULTIHANCE

Product Number

3

Dosage Form

-

Strength

7.935GM/15ML (529MG/ML)

Approval Date

2004-11-23

21357 / 3

Active Ingredient

GADOBENATE DIMEGLUMINE

Application Number

21357

Product Number

3

Dosage Form

-

Strength

7.935GM/15ML (529MG/ML)

Approval Date

2004-11-23

Regulatory Status

RX

2004
23 Nov
RX Application: 21357

Drug Name

MULTIHANCE

Product Number

4

Dosage Form

-

Strength

10.58GM/20ML (529MG/ML)

Approval Date

2004-11-23

21357 / 4

Active Ingredient

GADOBENATE DIMEGLUMINE

Application Number

21357

Product Number

4

Dosage Form

-

Strength

10.58GM/20ML (529MG/ML)

Approval Date

2004-11-23

Regulatory Status

RX

2004
23 Nov
RX Application: 21358

Drug Name

MULTIHANCE MULTIPACK

Product Number

1

Dosage Form

-

Strength

26.45GM/50ML (529MG/ML)

Approval Date

2004-11-23

21358 / 1

Active Ingredient

GADOBENATE DIMEGLUMINE

Application Number

21358

Product Number

1

Dosage Form

-

Strength

26.45GM/50ML (529MG/ML)

Approval Date

2004-11-23

Regulatory Status

RX

2004
23 Nov
RX Application: 21358

Drug Name

MULTIHANCE MULTIPACK

Product Number

2

Dosage Form

-

Strength

52.9GM/100ML (529MG/ML)

Approval Date

2004-11-23

21358 / 2

Active Ingredient

GADOBENATE DIMEGLUMINE

Application Number

21358

Product Number

2

Dosage Form

-

Strength

52.9GM/100ML (529MG/ML)

Approval Date

2004-11-23

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 12968

Drug Name

ORAGRAFIN CALCIUM

Product Number

1

Dosage Form

-

Strength

3GM/PACKET

Approval Date

1982-01-01

12968 / 1

Active Ingredient

IPODATE CALCIUM

Application Number

12968

Product Number

1

Dosage Form

-

Strength

3GM/PACKET

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12967

Drug Name

ORAGRAFIN SODIUM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

12967 / 1

Active Ingredient

IPODATE SODIUM

Application Number

12967

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17680

Drug Name

PHOSPHOTEC

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

17680 / 1

Active Ingredient

TECHNETIUM TC-99M PYROPHOSPHATE KIT

Application Number

17680

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10927

Drug Name

PHOSPHOTOPE

Product Number

1

Dosage Form

-

Strength

1-8mCi/VIAL

Approval Date

1982-01-01

10927 / 1

Active Ingredient

SODIUM PHOSPHATE P-32

Application Number

10927

Product Number

1

Dosage Form

-

Strength

1-8mCi/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
16 Nov
RX Application: 20131

Drug Name

PROHANCE

Product Number

1

Dosage Form

-

Strength

279.3MG/ML

Approval Date

1992-11-16

20131 / 1

Active Ingredient

GADOTERIDOL

Application Number

20131

Product Number

1

Dosage Form

-

Strength

279.3MG/ML

Approval Date

1992-11-16

Regulatory Status

RX

2003
09 Oct
RX Application: 21489

Drug Name

PROHANCE MULTIPACK

Product Number

1

Dosage Form

-

Strength

279.3MG/ML

Approval Date

2003-10-09

21489 / 1

Active Ingredient

GADOTERIDOL

Application Number

21489

Product Number

1

Dosage Form

-

Strength

279.3MG/ML

Approval Date

2003-10-09

Regulatory Status

RX

2016
15 Jan
RX Application: 208143

Drug Name

READI-CAT 2

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2016-01-15

208143 / 1

Active Ingredient

BARIUM SULFATE

Application Number

208143

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2016-01-15

Regulatory Status

RX

2016
15 Jan
RX Application: 208143

Drug Name

READI-CAT 2 SMOOTHIE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2016-01-15

208143 / 2

Active Ingredient

BARIUM SULFATE

Application Number

208143

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2016-01-15

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 10040

Drug Name

RENO-30

Product Number

21

Dosage Form

-

Strength

30%

Approval Date

1982-01-01

10040 / 21

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

10040

Product Number

21

Dosage Form

-

Strength

30%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10040

Drug Name

RENO-60

Product Number

16

Dosage Form

-

Strength

60%

Approval Date

1982-01-01

10040 / 16

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

10040

Product Number

16

Dosage Form

-

Strength

60%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10040

Drug Name

RENO-DIP

Product Number

12

Dosage Form

-

Strength

30%

Approval Date

1982-01-01

10040 / 12

Active Ingredient

DIATRIZOATE MEGLUMINE

Application Number

10040

Product Number

12

Dosage Form

-

Strength

30%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
01 Jun
Discontinued Application: 89347

Drug Name

RENOCAL-76

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1988-06-01

89347 / 1

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

89347

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1988-06-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10040

Drug Name

RENOGRAFIN-60

Product Number

6

Dosage Form

-

Strength

52%;8%

Approval Date

1982-01-01

10040 / 6

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

10040

Product Number

6

Dosage Form

-

Strength

52%;8%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10040

Drug Name

RENOGRAFIN-76

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1982-01-01

10040 / 1

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

10040

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17045

Drug Name

RENOTEC

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

17045 / 1

Active Ingredient

TECHNETIUM TC-99M FERPENTETATE KIT

Application Number

17045

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10040

Drug Name

RENOVIST

Product Number

20

Dosage Form

-

Strength

34.3%;35%

Approval Date

1982-01-01

10040 / 20

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

10040

Product Number

20

Dosage Form

-

Strength

34.3%;35%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10040

Drug Name

RENOVIST II

Product Number

19

Dosage Form

-

Strength

28.5%;29.1%

Approval Date

1982-01-01

10040 / 19

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

10040

Product Number

19

Dosage Form

-

Strength

28.5%;29.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17902

Drug Name

RENOVUE-65

Product Number

1

Dosage Form

-

Strength

65%

Approval Date

1982-01-01

17902 / 1

Active Ingredient

IODAMIDE MEGLUMINE

Application Number

17902

Product Number

1

Dosage Form

-

Strength

65%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17903

Drug Name

RENOVUE-DIP

Product Number

1

Dosage Form

-

Strength

24%

Approval Date

1982-01-01

17903 / 1

Active Ingredient

IODAMIDE MEGLUMINE

Application Number

17903

Product Number

1

Dosage Form

-

Strength

24%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16224

Drug Name

ROBENGATOPE

Product Number

1

Dosage Form

-

Strength

0.5mCi/VIAL

Approval Date

1982-01-01

16224 / 1

Active Ingredient

ROSE BENGAL SODIUM I-131

Application Number

16224

Product Number

1

Dosage Form

-

Strength

0.5mCi/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16224

Drug Name

ROBENGATOPE

Product Number

2

Dosage Form

-

Strength

1mCi/VIAL

Approval Date

1982-01-01

16224 / 2

Active Ingredient

ROSE BENGAL SODIUM I-131

Application Number

16224

Product Number

2

Dosage Form

-

Strength

1mCi/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16224

Drug Name

ROBENGATOPE

Product Number

3

Dosage Form

-

Strength

2mCi/VIAL

Approval Date

1982-01-01

16224 / 3

Active Ingredient

ROSE BENGAL SODIUM I-131

Application Number

16224

Product Number

3

Dosage Form

-

Strength

2mCi/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17047

Drug Name

SETHOTOPE

Product Number

1

Dosage Form

-

Strength

85-550uCi/ML

Approval Date

1982-01-01

17047 / 1

Active Ingredient

SELENOMETHIONINE SE-75

Application Number

17047

Product Number

1

Dosage Form

-

Strength

85-550uCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11324

Drug Name

SINOGRAFIN

Product Number

2

Dosage Form

-

Strength

52.7%;26.8%

Approval Date

1982-01-01

11324 / 2

Active Ingredient

DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE

Application Number

11324

Product Number

2

Dosage Form

-

Strength

52.7%;26.8%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
29 Oct
Discontinued Application: 20773

Drug Name

SONORX

Product Number

1

Dosage Form

-

Strength

7.5MG/ML

Approval Date

1998-10-29

20773 / 1

Active Ingredient

SIMETHICONE-CELLULOSE

Application Number

20773

Product Number

1

Dosage Form

-

Strength

7.5MG/ML

Approval Date

1998-10-29

Regulatory Status

Discontinued

2017
04 Aug
RX Application: 208143

Drug Name

TAGITOL V

Product Number

5

Dosage Form

-

Strength

40%

Approval Date

2017-08-04

208143 / 5

Active Ingredient

BARIUM SULFATE

Application Number

208143

Product Number

5

Dosage Form

-

Strength

40%

Approval Date

2017-08-04

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 16923

Drug Name

TESULOID

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

16923 / 1

Active Ingredient

TECHNETIUM TC-99M SULFUR COLLOID KIT

Application Number

16923

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
30 Dec
Discontinued Application: 18548

Drug Name

THALLOUS CHLORIDE TL 201

Product Number

1

Dosage Form

-

Strength

1mCi/ML

Approval Date

1982-12-30

18548 / 1

Active Ingredient

THALLOUS CHLORIDE TL-201

Application Number

18548

Product Number

1

Dosage Form

-

Strength

1mCi/ML

Approval Date

1982-12-30

Regulatory Status

Discontinued

2018
26 Mar
RX Application: 208143

Drug Name

VARIBAR HONEY

Product Number

7

Dosage Form

-

Strength

40%

Approval Date

2018-03-26

208143 / 7

Active Ingredient

BARIUM SULFATE

Application Number

208143

Product Number

7

Dosage Form

-

Strength

40%

Approval Date

2018-03-26

Regulatory Status

RX

2017
07 Jul
RX Application: 208143

Drug Name

VARIBAR NECTAR

Product Number

4

Dosage Form

-

Strength

40%

Approval Date

2017-07-07

208143 / 4

Active Ingredient

BARIUM SULFATE

Application Number

208143

Product Number

4

Dosage Form

-

Strength

40%

Approval Date

2017-07-07

Regulatory Status

RX

2016
14 Oct
RX Application: 208844

Drug Name

VARIBAR PUDDING

Product Number

1

Dosage Form

-

Strength

40%

Approval Date

2016-10-14

208844 / 1

Active Ingredient

BARIUM SULFATE

Application Number

208844

Product Number

1

Dosage Form

-

Strength

40%

Approval Date

2016-10-14

Regulatory Status

RX

2018
23 Jan
RX Application: 208143

Drug Name

VARIBAR THIN HONEY

Product Number

6

Dosage Form

-

Strength

40%

Approval Date

2018-01-23

208143 / 6

Active Ingredient

BARIUM SULFATE

Application Number

208143

Product Number

6

Dosage Form

-

Strength

40%

Approval Date

2018-01-23

Regulatory Status

RX

2019
30 Apr
RX Application: 208036

Drug Name

VARIBAR THIN LIQUID

Product Number

4

Dosage Form

-

Strength

81%

Approval Date

2019-04-30

208036 / 4

Active Ingredient

BARIUM SULFATE

Application Number

208036

Product Number

4

Dosage Form

-

Strength

81%

Approval Date

2019-04-30

Regulatory Status

RX

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Drug Status Breakdown
107 total
  • RX
  • Discontinued
  • Unclassified
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FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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Drug Name

CARDIOGEN-82

Application Number

19414

Product Number

1

Active Ingredient

RUBIDIUM CHLORIDE RB-82

Dosage Form

-

Strength

N/A

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