UCB Pharma S.A RX
FDA Approved Drugs

UCB Pharma S.A RX

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 33
  • Latest Approval Date Nov 03, 2025
  • Data Source FDA
  • First Approval Date Nov 30, 1999
All
78
View
Unclassified
4
View
Discontinued
41
View
RX
33
View
Company Overview

Company

UCB Pharma S.A RX

Country

Belgium

Website

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Email

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Company Snapshot

UCB Pharma S.A RX

Allée de la Recherche, 60 1070 Brussels

Belgium

www.ucb.com/ View on Map
FDA Approved Drug Records ( 33 records )
2016
12 May
RX Application: 205836

Drug Name

BRIVIACT

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-05-12

205836 / 1

Active Ingredient

BRIVARACETAM

Application Number

205836

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-05-12

Regulatory Status

RX

2016
12 May
RX Application: 205836

Drug Name

BRIVIACT

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2016-05-12

205836 / 2

Active Ingredient

BRIVARACETAM

Application Number

205836

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2016-05-12

Regulatory Status

RX

2016
12 May
RX Application: 205836

Drug Name

BRIVIACT

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2016-05-12

205836 / 3

Active Ingredient

BRIVARACETAM

Application Number

205836

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2016-05-12

Regulatory Status

RX

2016
12 May
RX Application: 205836

Drug Name

BRIVIACT

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2016-05-12

205836 / 4

Active Ingredient

BRIVARACETAM

Application Number

205836

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2016-05-12

Regulatory Status

RX

2016
12 May
RX Application: 205836

Drug Name

BRIVIACT

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2016-05-12

205836 / 5

Active Ingredient

BRIVARACETAM

Application Number

205836

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2016-05-12

Regulatory Status

RX

2016
12 May
RX Application: 205837

Drug Name

BRIVIACT

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2016-05-12

205837 / 1

Active Ingredient

BRIVARACETAM

Application Number

205837

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2016-05-12

Regulatory Status

RX

2016
12 May
RX Application: 205838

Drug Name

BRIVIACT

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2016-05-12

205838 / 1

Active Ingredient

BRIVARACETAM

Application Number

205838

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2016-05-12

Regulatory Status

RX

2020
25 Jun
RX Application: 212102

Drug Name

FINTEPLA

Product Number

1

Dosage Form

-

Strength

EQ 2.2MG BASE/ML

Approval Date

2020-06-25

212102 / 1

Active Ingredient

FENFLURAMINE HYDROCHLORIDE

Application Number

212102

Product Number

1

Dosage Form

-

Strength

EQ 2.2MG BASE/ML

Approval Date

2020-06-25

Regulatory Status

RX

1999
30 Nov
RX Application: 21035

Drug Name

KEPPRA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-11-30

21035 / 1

Active Ingredient

LEVETIRACETAM

Application Number

21035

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-11-30

Regulatory Status

RX

1999
30 Nov
RX Application: 21035

Drug Name

KEPPRA

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-11-30

21035 / 2

Active Ingredient

LEVETIRACETAM

Application Number

21035

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-11-30

Regulatory Status

RX

1999
30 Nov
RX Application: 21035

Drug Name

KEPPRA

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

1999-11-30

21035 / 3

Active Ingredient

LEVETIRACETAM

Application Number

21035

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

1999-11-30

Regulatory Status

RX

2006
06 Jan
RX Application: 21035

Drug Name

KEPPRA

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2006-01-06

21035 / 4

Active Ingredient

LEVETIRACETAM

Application Number

21035

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2006-01-06

Regulatory Status

RX

2003
15 Jul
RX Application: 21505

Drug Name

KEPPRA

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2003-07-15

21505 / 1

Active Ingredient

LEVETIRACETAM

Application Number

21505

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2003-07-15

Regulatory Status

RX

2006
31 Jul
RX Application: 21872

Drug Name

KEPPRA

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2006-07-31

21872 / 1

Active Ingredient

LEVETIRACETAM

Application Number

21872

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2006-07-31

Regulatory Status

RX

2008
12 Sep
RX Application: 22285

Drug Name

KEPPRA XR

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-09-12

22285 / 1

Active Ingredient

LEVETIRACETAM

Application Number

22285

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-09-12

Regulatory Status

RX

2009
12 Feb
RX Application: 22285

Drug Name

KEPPRA XR

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2009-02-12

22285 / 2

Active Ingredient

LEVETIRACETAM

Application Number

22285

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2009-02-12

Regulatory Status

RX

2025
03 Nov
RX Application: 219792

Drug Name

KYGEVVI

Product Number

1

Dosage Form

-

Strength

2GM/PACKET;2GM/PACKET

Approval Date

2025-11-03

219792 / 1

Active Ingredient

DOXECITINE; DOXRIBTIMINE

Application Number

219792

Product Number

1

Dosage Form

-

Strength

2GM/PACKET;2GM/PACKET

Approval Date

2025-11-03

Regulatory Status

RX

2019
17 May
RX Application: 211321

Drug Name

NAYZILAM

Product Number

1

Dosage Form

-

Strength

5MG/SPRAY

Approval Date

2019-05-17

211321 / 1

Active Ingredient

MIDAZOLAM

Application Number

211321

Product Number

1

Dosage Form

-

Strength

5MG/SPRAY

Approval Date

2019-05-17

Regulatory Status

RX

2007
09 May
RX Application: 21829

Drug Name

NEUPRO

Product Number

1

Dosage Form

-

Strength

2MG/24HR

Approval Date

2007-05-09

21829 / 1

Active Ingredient

ROTIGOTINE

Application Number

21829

Product Number

1

Dosage Form

-

Strength

2MG/24HR

Approval Date

2007-05-09

Regulatory Status

RX

2007
09 May
RX Application: 21829

Drug Name

NEUPRO

Product Number

2

Dosage Form

-

Strength

4MG/24HR

Approval Date

2007-05-09

21829 / 2

Active Ingredient

ROTIGOTINE

Application Number

21829

Product Number

2

Dosage Form

-

Strength

4MG/24HR

Approval Date

2007-05-09

Regulatory Status

RX

2007
09 May
RX Application: 21829

Drug Name

NEUPRO

Product Number

3

Dosage Form

-

Strength

6MG/24HR

Approval Date

2007-05-09

21829 / 3

Active Ingredient

ROTIGOTINE

Application Number

21829

Product Number

3

Dosage Form

-

Strength

6MG/24HR

Approval Date

2007-05-09

Regulatory Status

RX

2012
02 Apr
RX Application: 21829

Drug Name

NEUPRO

Product Number

4

Dosage Form

-

Strength

1MG/24HR

Approval Date

2012-04-02

21829 / 4

Active Ingredient

ROTIGOTINE

Application Number

21829

Product Number

4

Dosage Form

-

Strength

1MG/24HR

Approval Date

2012-04-02

Regulatory Status

RX

2012
02 Apr
RX Application: 21829

Drug Name

NEUPRO

Product Number

5

Dosage Form

-

Strength

3MG/24HR

Approval Date

2012-04-02

21829 / 5

Active Ingredient

ROTIGOTINE

Application Number

21829

Product Number

5

Dosage Form

-

Strength

3MG/24HR

Approval Date

2012-04-02

Regulatory Status

RX

2012
02 Apr
RX Application: 21829

Drug Name

NEUPRO

Product Number

6

Dosage Form

-

Strength

8MG/24HR

Approval Date

2012-04-02

21829 / 6

Active Ingredient

ROTIGOTINE

Application Number

21829

Product Number

6

Dosage Form

-

Strength

8MG/24HR

Approval Date

2012-04-02

Regulatory Status

RX

2008
28 Oct
RX Application: 22253

Drug Name

VIMPAT

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2008-10-28

22253 / 1

Active Ingredient

LACOSAMIDE

Application Number

22253

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2008-10-28

Regulatory Status

RX

2008
28 Oct
RX Application: 22253

Drug Name

VIMPAT

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2008-10-28

22253 / 2

Active Ingredient

LACOSAMIDE

Application Number

22253

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2008-10-28

Regulatory Status

RX

2008
28 Oct
RX Application: 22253

Drug Name

VIMPAT

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2008-10-28

22253 / 3

Active Ingredient

LACOSAMIDE

Application Number

22253

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2008-10-28

Regulatory Status

RX

2008
28 Oct
RX Application: 22253

Drug Name

VIMPAT

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2008-10-28

22253 / 4

Active Ingredient

LACOSAMIDE

Application Number

22253

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2008-10-28

Regulatory Status

RX

2008
28 Oct
RX Application: 22254

Drug Name

VIMPAT

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2008-10-28

22254 / 1

Active Ingredient

LACOSAMIDE

Application Number

22254

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2008-10-28

Regulatory Status

RX

2010
20 Apr
RX Application: 22255

Drug Name

VIMPAT

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2010-04-20

22255 / 1

Active Ingredient

LACOSAMIDE

Application Number

22255

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2010-04-20

Regulatory Status

RX

2023
17 Oct
RX Application: 216834

Drug Name

ZILBRYSQ

Product Number

1

Dosage Form

-

Strength

EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)

Approval Date

2023-10-17

216834 / 1

Active Ingredient

ZILUCOPLAN SODIUM

Application Number

216834

Product Number

1

Dosage Form

-

Strength

EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)

Approval Date

2023-10-17

Regulatory Status

RX

2023
17 Oct
RX Application: 216834

Drug Name

ZILBRYSQ

Product Number

2

Dosage Form

-

Strength

EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)

Approval Date

2023-10-17

216834 / 2

Active Ingredient

ZILUCOPLAN SODIUM

Application Number

216834

Product Number

2

Dosage Form

-

Strength

EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)

Approval Date

2023-10-17

Regulatory Status

RX

2023
17 Oct
RX Application: 216834

Drug Name

ZILBRYSQ

Product Number

3

Dosage Form

-

Strength

EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)

Approval Date

2023-10-17

216834 / 3

Active Ingredient

ZILUCOPLAN SODIUM

Application Number

216834

Product Number

3

Dosage Form

-

Strength

EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)

Approval Date

2023-10-17

Regulatory Status

RX

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Drug Status Breakdown
33 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

BRIVIACT

Application Number

205836

Product Number

1

Active Ingredient

BRIVARACETAM

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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