Synthon Pharmaceuticals
FDA Approved Drugs

Synthon Pharmaceuticals

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.

Discontinued RX Unclassified
  • Total Records 32
  • Latest Approval Date Sep 25, 2024
  • Data Source FDA
  • First Approval Date Jan 17, 2001
All
32
View
Unclassified
2
View
Discontinued
26
View
RX
4
View
Company Overview

Company

Synthon Pharmaceuticals

Country

Netherlands

Website

Visit Website

Email

communications@synthon.com

Social Profiles

Company Snapshot

Synthon Pharmaceuticals

PO Box 70716503 GN NijmegenThe Netherlands

Netherlands

www.synthon.com/ communications@synthon.com View on Map
FDA Approved Drug Records ( 32 records )
2007
27 Sep
Discontinued Application: 22026

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-09-27

22026 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

22026

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-09-27

Regulatory Status

Discontinued

2007
27 Sep
Discontinued Application: 22026

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-09-27

22026 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

22026

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-09-27

Regulatory Status

Discontinued

2007
27 Sep
Discontinued Application: 22026

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-09-27

22026 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

22026

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-09-27

Regulatory Status

Discontinued

2007
27 Jun
Discontinued Application: 77080

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-06-27

77080 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77080

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-06-27

Regulatory Status

Discontinued

2007
27 Jun
Discontinued Application: 77080

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-06-27

77080 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77080

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-06-27

Regulatory Status

Discontinued

2007
27 Jun
Discontinued Application: 77080

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-27

77080 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77080

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-27

Regulatory Status

Discontinued

2010
28 Jun
Discontinued Application: 78322

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

78322 / 1

Active Ingredient

ANASTROZOLE

Application Number

78322

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

Regulatory Status

Discontinued

2009
06 Jul
Discontinued Application: 77973

Drug Name

BICALUTAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2009-07-06

77973 / 1

Active Ingredient

BICALUTAMIDE

Application Number

77973

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2009-07-06

Regulatory Status

Discontinued

2001
17 Jan
Discontinued Application: 75899

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-01-17

75899 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75899

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2001-01-17

Regulatory Status

Discontinued

2001
17 Jan
Discontinued Application: 75899

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-01-17

75899 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75899

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2001-01-17

Regulatory Status

Discontinued

2001
17 Jan
Discontinued Application: 75899

Drug Name

FLUVOXAMINE MALEATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-01-17

75899 / 3

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75899

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2001-01-17

Regulatory Status

Discontinued

2024
25 Sep
RX Application: 203857

Drug Name

GLATIRAMER ACETATE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2024-09-25

203857 / 1

Active Ingredient

GLATIRAMER ACETATE

Application Number

203857

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2024-09-25

Regulatory Status

RX

2024
25 Sep
RX Application: 206873

Drug Name

GLATIRAMER ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2024-09-25

206873 / 1

Active Ingredient

GLATIRAMER ACETATE

Application Number

206873

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2024-09-25

Regulatory Status

RX

2011
03 Jun
Discontinued Application: 90196

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

90196 / 1

Active Ingredient

LETROZOLE

Application Number

90196

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

Regulatory Status

Discontinued

2010
26 Nov
RX Application: 90229

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-11-26

90229 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

90229

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-11-26

Regulatory Status

RX

-
Unclassified Application: 219236

Drug Name

OZANIMOD

Product Number

2

Dosage Form

-

Strength

0.46MG

Approval Date

-

219236 / 2

Active Ingredient

OZANIMOD

Application Number

219236

Product Number

2

Dosage Form

-

Strength

0.46MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 219236

Drug Name

OZANIMOD

Product Number

3

Dosage Form

-

Strength

0.23MG

Approval Date

-

219236 / 3

Active Ingredient

OZANIMOD

Application Number

219236

Product Number

3

Dosage Form

-

Strength

0.23MG

Approval Date

-

Regulatory Status

Unclassified

2009
22 Oct
Discontinued Application: 78187

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2009-10-22

78187 / 1

Active Ingredient

RISPERIDONE

Application Number

78187

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2009-10-22

Regulatory Status

Discontinued

2009
22 Oct
Discontinued Application: 78187

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2009-10-22

78187 / 2

Active Ingredient

RISPERIDONE

Application Number

78187

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2009-10-22

Regulatory Status

Discontinued

2009
22 Oct
Discontinued Application: 78187

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2009-10-22

78187 / 3

Active Ingredient

RISPERIDONE

Application Number

78187

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2009-10-22

Regulatory Status

Discontinued

2009
22 Oct
Discontinued Application: 78187

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2009-10-22

78187 / 4

Active Ingredient

RISPERIDONE

Application Number

78187

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2009-10-22

Regulatory Status

Discontinued

2009
22 Oct
Discontinued Application: 78187

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2009-10-22

78187 / 5

Active Ingredient

RISPERIDONE

Application Number

78187

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2009-10-22

Regulatory Status

Discontinued

2009
22 Oct
Discontinued Application: 78187

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2009-10-22

78187 / 6

Active Ingredient

RISPERIDONE

Application Number

78187

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2009-10-22

Regulatory Status

Discontinued

2007
09 Oct
Discontinued Application: 21961

Drug Name

SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-10-09

21961 / 1

Active Ingredient

SIMVASTATIN

Application Number

21961

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-10-09

Regulatory Status

Discontinued

2007
09 Oct
Discontinued Application: 21961

Drug Name

SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-10-09

21961 / 2

Active Ingredient

SIMVASTATIN

Application Number

21961

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2007-10-09

Regulatory Status

Discontinued

2007
09 Oct
Discontinued Application: 21961

Drug Name

SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2007-10-09

21961 / 3

Active Ingredient

SIMVASTATIN

Application Number

21961

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2007-10-09

Regulatory Status

Discontinued

2007
09 Oct
Discontinued Application: 21961

Drug Name

SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2007-10-09

21961 / 4

Active Ingredient

SIMVASTATIN

Application Number

21961

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2007-10-09

Regulatory Status

Discontinued

2010
27 Apr
RX Application: 78801

Drug Name

TAMSULOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-04-27

78801 / 1

Active Ingredient

TAMSULOSIN HYDROCHLORIDE

Application Number

78801

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-04-27

Regulatory Status

RX

2007
23 Apr
Discontinued Application: 77540

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

77540 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77540

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 77540

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

77540 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77540

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2011
12 Apr
Discontinued Application: 78483

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2011-04-12

78483 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78483

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2011-04-12

Regulatory Status

Discontinued

2011
06 Jun
Discontinued Application: 78483

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2011-06-06

78483 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78483

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2011-06-06

Regulatory Status

Discontinued

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Drug Status Breakdown
32 total
  • Discontinued
  • RX
  • Unclassified
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

AMLODIPINE BESYLATE

Application Number

22026

Product Number

1

Active Ingredient

AMLODIPINE BESYLATE

Dosage Form

-

Strength

EQ 2.5MG BASE

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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