IBSA Institut Biochimique
FDA Approved Drugs

IBSA Institut Biochimique

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
  • Total Records 36
  • Latest Approval Date Dec 16, 2025
  • Data Source FDA
  • First Approval Date Oct 13, 2006
Company Overview

Company

IBSA Institut Biochimique

Country

Switzerland

Website

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Company Snapshot

IBSA Institut Biochimique

Via del Piano, 29 CH 6915 Pambio-Noranco, Lugano

Switzerland

www.ibsagroup.com/ View on Map
FDA Approved Drug Records ( 36 records )
2007
31 Jan
RX Application: 21234

Drug Name

FLECTOR

Product Number

1

Dosage Form

-

Strength

1.3%

Approval Date

2007-01-31

21234 / 1

Active Ingredient

DICLOFENAC EPOLAMINE

Application Number

21234

Product Number

1

Dosage Form

-

Strength

1.3%

Approval Date

2007-01-31

Regulatory Status

RX

2020
30 Apr
RX Application: 209190

Drug Name

LIDOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2020-04-30

209190 / 1

Active Ingredient

LIDOCAINE

Application Number

209190

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2020-04-30

Regulatory Status

RX

2006
13 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

2

Dosage Form

-

Strength

0.025MG

Approval Date

2006-10-13

21924 / 2

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

2

Dosage Form

-

Strength

0.025MG

Approval Date

2006-10-13

Regulatory Status

RX

2006
13 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

3

Dosage Form

-

Strength

0.05MG

Approval Date

2006-10-13

21924 / 3

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

3

Dosage Form

-

Strength

0.05MG

Approval Date

2006-10-13

Regulatory Status

RX

2006
13 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

4

Dosage Form

-

Strength

0.075MG

Approval Date

2006-10-13

21924 / 4

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

4

Dosage Form

-

Strength

0.075MG

Approval Date

2006-10-13

Regulatory Status

RX

2006
13 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

5

Dosage Form

-

Strength

0.1MG

Approval Date

2006-10-13

21924 / 5

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

5

Dosage Form

-

Strength

0.1MG

Approval Date

2006-10-13

Regulatory Status

RX

2006
13 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

6

Dosage Form

-

Strength

0.125MG

Approval Date

2006-10-13

21924 / 6

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

6

Dosage Form

-

Strength

0.125MG

Approval Date

2006-10-13

Regulatory Status

RX

2006
13 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

7

Dosage Form

-

Strength

0.15MG

Approval Date

2006-10-13

21924 / 7

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

7

Dosage Form

-

Strength

0.15MG

Approval Date

2006-10-13

Regulatory Status

RX

2009
02 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

8

Dosage Form

-

Strength

0.112MG

Approval Date

2009-10-02

21924 / 8

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

8

Dosage Form

-

Strength

0.112MG

Approval Date

2009-10-02

Regulatory Status

RX

2009
02 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

9

Dosage Form

-

Strength

0.137MG

Approval Date

2009-10-02

21924 / 9

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

9

Dosage Form

-

Strength

0.137MG

Approval Date

2009-10-02

Regulatory Status

RX

2009
02 Oct
RX Application: 21924

Drug Name

TIROSINT

Product Number

10

Dosage Form

-

Strength

0.088MG

Approval Date

2009-10-02

21924 / 10

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

10

Dosage Form

-

Strength

0.088MG

Approval Date

2009-10-02

Regulatory Status

RX

2017
25 Apr
RX Application: 21924

Drug Name

TIROSINT

Product Number

11

Dosage Form

-

Strength

0.175MG

Approval Date

2017-04-25

21924 / 11

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

11

Dosage Form

-

Strength

0.175MG

Approval Date

2017-04-25

Regulatory Status

RX

2017
25 Apr
RX Application: 21924

Drug Name

TIROSINT

Product Number

12

Dosage Form

-

Strength

0.2MG

Approval Date

2017-04-25

21924 / 12

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

12

Dosage Form

-

Strength

0.2MG

Approval Date

2017-04-25

Regulatory Status

RX

2007
01 Aug
RX Application: 21924

Drug Name

TIROSINT

Product Number

13

Dosage Form

-

Strength

0.013MG

Approval Date

2007-08-01

21924 / 13

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

13

Dosage Form

-

Strength

0.013MG

Approval Date

2007-08-01

Regulatory Status

RX

2022
22 Jun
RX Application: 21924

Drug Name

TIROSINT

Product Number

14

Dosage Form

-

Strength

0.0375MG

Approval Date

2022-06-22

21924 / 14

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

14

Dosage Form

-

Strength

0.0375MG

Approval Date

2022-06-22

Regulatory Status

RX

2022
22 Jun
RX Application: 21924

Drug Name

TIROSINT

Product Number

15

Dosage Form

-

Strength

0.044MG

Approval Date

2022-06-22

21924 / 15

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

15

Dosage Form

-

Strength

0.044MG

Approval Date

2022-06-22

Regulatory Status

RX

2022
22 Jun
RX Application: 21924

Drug Name

TIROSINT

Product Number

16

Dosage Form

-

Strength

0.0625MG

Approval Date

2022-06-22

21924 / 16

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21924

Product Number

16

Dosage Form

-

Strength

0.0625MG

Approval Date

2022-06-22

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

1

Dosage Form

-

Strength

13MCG/ML

Approval Date

2016-12-15

206977 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

1

Dosage Form

-

Strength

13MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

2

Dosage Form

-

Strength

25MCG/ML

Approval Date

2016-12-15

206977 / 2

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

2

Dosage Form

-

Strength

25MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

3

Dosage Form

-

Strength

50MCG/ML

Approval Date

2016-12-15

206977 / 3

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

3

Dosage Form

-

Strength

50MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

4

Dosage Form

-

Strength

75MCG/ML

Approval Date

2016-12-15

206977 / 4

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

4

Dosage Form

-

Strength

75MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

5

Dosage Form

-

Strength

88MCG/ML

Approval Date

2016-12-15

206977 / 5

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

5

Dosage Form

-

Strength

88MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

6

Dosage Form

-

Strength

100MCG/ML

Approval Date

2016-12-15

206977 / 6

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

6

Dosage Form

-

Strength

100MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

7

Dosage Form

-

Strength

112MCG/ML

Approval Date

2016-12-15

206977 / 7

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

7

Dosage Form

-

Strength

112MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

8

Dosage Form

-

Strength

125MCG/ML

Approval Date

2016-12-15

206977 / 8

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

8

Dosage Form

-

Strength

125MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

9

Dosage Form

-

Strength

137MCG/ML

Approval Date

2016-12-15

206977 / 9

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

9

Dosage Form

-

Strength

137MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

10

Dosage Form

-

Strength

150MCG/ML

Approval Date

2016-12-15

206977 / 10

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

10

Dosage Form

-

Strength

150MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

11

Dosage Form

-

Strength

175MCG/ML

Approval Date

2016-12-15

206977 / 11

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

11

Dosage Form

-

Strength

175MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2016
15 Dec
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

12

Dosage Form

-

Strength

200MCG/ML

Approval Date

2016-12-15

206977 / 12

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

12

Dosage Form

-

Strength

200MCG/ML

Approval Date

2016-12-15

Regulatory Status

RX

2021
13 Jan
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

13

Dosage Form

-

Strength

37.5MCG/ML

Approval Date

2021-01-13

206977 / 13

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

13

Dosage Form

-

Strength

37.5MCG/ML

Approval Date

2021-01-13

Regulatory Status

RX

2021
13 Jan
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

14

Dosage Form

-

Strength

44MCG/ML

Approval Date

2021-01-13

206977 / 14

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

14

Dosage Form

-

Strength

44MCG/ML

Approval Date

2021-01-13

Regulatory Status

RX

2021
13 Jan
RX Application: 206977

Drug Name

TIROSINT-SOL

Product Number

15

Dosage Form

-

Strength

62.5MCG/ML

Approval Date

2021-01-13

206977 / 15

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

206977

Product Number

15

Dosage Form

-

Strength

62.5MCG/ML

Approval Date

2021-01-13

Regulatory Status

RX

2025
16 Dec
RX Application: 210858

Drug Name

VYBRIQUE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2025-12-16

210858 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

210858

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2025-12-16

Regulatory Status

RX

2025
16 Dec
RX Application: 210858

Drug Name

VYBRIQUE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-12-16

210858 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

210858

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2025-12-16

Regulatory Status

RX

2025
16 Dec
RX Application: 210858

Drug Name

VYBRIQUE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2025-12-16

210858 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

210858

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2025-12-16

Regulatory Status

RX

2025
16 Dec
RX Application: 210858

Drug Name

VYBRIQUE

Product Number

4

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2025-12-16

210858 / 4

Active Ingredient

SILDENAFIL CITRATE

Application Number

210858

Product Number

4

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2025-12-16

Regulatory Status

RX

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Drug Status Breakdown
36 total
  • RX
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

FLECTOR

Application Number

21234

Product Number

1

Active Ingredient

DICLOFENAC EPOLAMINE

Dosage Form

-

Strength

1.3%

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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