UCB Pharma S.A
FDA Approved Drugs
UCB Pharma S.A
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.
- Total Records 78
- Latest Approval Date Nov 03, 2025
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Snapshot
FDA Approved Drug Records ( 78 records )
Drug Name
ALBUTEROL SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1992-09-29
Active Ingredient
ALBUTEROL SULFATE
Application Number
73120
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1992-09-29
Regulatory Status
Discontinued
Drug Name
ALBUTEROL SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1992-09-29
Active Ingredient
ALBUTEROL SULFATE
Application Number
73121
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1992-09-29
Regulatory Status
Discontinued
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85864
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85935
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
85936
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86335
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86336
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
1982-01-01
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86337
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BIMZELX
Product Number
1
Dosage Form
-
Strength
160ML
Approval Date
-
Active Ingredient
BIMEKIZUMAB-BKZX
Application Number
761151
Product Number
1
Dosage Form
-
Strength
160ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
BIPHETAMINE 12.5
Product Number
7
Dosage Form
-
Strength
EQ 6.25MG BASE;EQ 6.25MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX
Application Number
10093
Product Number
7
Dosage Form
-
Strength
EQ 6.25MG BASE;EQ 6.25MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BIPHETAMINE 20
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;EQ 10MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX
Application Number
10093
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;EQ 10MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BIPHETAMINE 7.5
Product Number
9
Dosage Form
-
Strength
EQ 3.75MG BASE;EQ 3.75MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX
Application Number
10093
Product Number
9
Dosage Form
-
Strength
EQ 3.75MG BASE;EQ 3.75MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BRIVIACT
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2016-05-12
Active Ingredient
BRIVARACETAM
Application Number
205836
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2016-05-12
Regulatory Status
RX
Drug Name
BRIVIACT
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2016-05-12
Active Ingredient
BRIVARACETAM
Application Number
205836
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2016-05-12
Regulatory Status
RX
Drug Name
BRIVIACT
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2016-05-12
Active Ingredient
BRIVARACETAM
Application Number
205836
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2016-05-12
Regulatory Status
RX
Drug Name
BRIVIACT
Product Number
4
Dosage Form
-
Strength
75MG
Approval Date
2016-05-12
Active Ingredient
BRIVARACETAM
Application Number
205836
Product Number
4
Dosage Form
-
Strength
75MG
Approval Date
2016-05-12
Regulatory Status
RX
Drug Name
BRIVIACT
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2016-05-12
Active Ingredient
BRIVARACETAM
Application Number
205836
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2016-05-12
Regulatory Status
RX
Drug Name
BRIVIACT
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2016-05-12
Active Ingredient
BRIVARACETAM
Application Number
205837
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2016-05-12
Regulatory Status
RX
Drug Name
BRIVIACT
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2016-05-12
Active Ingredient
BRIVARACETAM
Application Number
205838
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2016-05-12
Regulatory Status
RX
Drug Name
CIMZIA
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
CERTOLIZUMAB PEGOL
Application Number
125160
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CO-GESIC
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1982-05-03
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
87757
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1982-05-03
Regulatory Status
Discontinued
Drug Name
CORSYM
Product Number
1
Dosage Form
-
Strength
EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML
Approval Date
-
Active Ingredient
CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX
Application Number
18050
Product Number
1
Dosage Form
-
Strength
EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DEXACORT
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG PHOSPHATE/INH
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
13413
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG PHOSPHATE/INH
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DEXACORT
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG PHOSPHATE/INH
Approval Date
1982-01-01
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
14242
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG PHOSPHATE/INH
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIETHYLPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
DIETHYLPROPION HYDROCHLORIDE
Application Number
85544
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FINTEPLA
Product Number
1
Dosage Form
-
Strength
EQ 2.2MG BASE/ML
Approval Date
2020-06-25
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
Drug Name
FLUXID
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2004-09-24
Active Ingredient
FAMOTIDINE
Application Number
21712
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2004-09-24
Regulatory Status
Discontinued
Drug Name
FLUXID
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2004-09-24
Active Ingredient
FAMOTIDINE
Application Number
21712
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2004-09-24
Regulatory Status
Discontinued
Drug Name
GASTROCROM
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1989-12-22
Active Ingredient
CROMOLYN SODIUM
Application Number
19188
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1989-12-22
Regulatory Status
Discontinued
Drug Name
GLUTETHIMIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
GLUTETHIMIDE
Application Number
85171
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;7.5MG
Approval Date
1996-11-21
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40134
Product Number
1
Dosage Form
-
Strength
650MG;7.5MG
Approval Date
1996-11-21
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
500MG;10MG
Approval Date
1997-08-13
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40210
Product Number
1
Dosage Form
-
Strength
500MG;10MG
Approval Date
1997-08-13
Regulatory Status
Discontinued
Drug Name
IONAMIN
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE RESIN COMPLEX
Application Number
11613
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
IONAMIN
Product Number
4
Dosage Form
-
Strength
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
PHENTERMINE RESIN COMPLEX
Application Number
11613
Product Number
4
Dosage Form
-
Strength
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
KEMSTRO
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-10-30
Active Ingredient
BACLOFEN
Application Number
21589
Product Number
1
Dosage Form
-
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-10-30
Regulatory Status
Discontinued
Drug Name
KEMSTRO
Product Number
2
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-10-30
Active Ingredient
BACLOFEN
Application Number
21589
Product Number
2
Dosage Form
-
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2003-10-30
Regulatory Status
Discontinued
Drug Name
KEPPRA
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1999-11-30
Active Ingredient
LEVETIRACETAM
Application Number
21035
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1999-11-30
Regulatory Status
RX
Drug Name
KEPPRA
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1999-11-30
Active Ingredient
LEVETIRACETAM
Application Number
21035
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1999-11-30
Regulatory Status
RX
Drug Name
KEPPRA
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
1999-11-30
Active Ingredient
LEVETIRACETAM
Application Number
21035
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
1999-11-30
Regulatory Status
RX
Drug Name
KEPPRA
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2006-01-06
Active Ingredient
LEVETIRACETAM
Application Number
21035
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2006-01-06
Regulatory Status
RX
Drug Name
KEPPRA
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2003-07-15
Active Ingredient
LEVETIRACETAM
Application Number
21505
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2003-07-15
Regulatory Status
RX
Drug Name
KEPPRA
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2006-07-31
Active Ingredient
LEVETIRACETAM
Application Number
21872
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2006-07-31
Regulatory Status
RX
Drug Name
KEPPRA XR
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2008-09-12
Active Ingredient
LEVETIRACETAM
Application Number
22285
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2008-09-12
Regulatory Status
RX
Drug Name
KEPPRA XR
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2009-02-12
Active Ingredient
LEVETIRACETAM
Application Number
22285
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2009-02-12
Regulatory Status
RX
Drug Name
KYGEVVI
Product Number
1
Dosage Form
-
Strength
2GM/PACKET;2GM/PACKET
Approval Date
2025-11-03
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
Drug Name
LORTAB
Product Number
1
Dosage Form
-
Strength
500MG;10MG
Approval Date
1996-01-26
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40100
Product Number
1
Dosage Form
-
Strength
500MG;10MG
Approval Date
1996-01-26
Regulatory Status
Discontinued
Drug Name
LORTAB
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1982-07-09
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
87722
Product Number
1
Dosage Form
-
Strength
500MG;5MG
Approval Date
1982-07-09
Regulatory Status
Discontinued
Drug Name
NAYZILAM
Product Number
1
Dosage Form
-
Strength
5MG/SPRAY
Approval Date
2019-05-17
Active Ingredient
MIDAZOLAM
Application Number
211321
Product Number
1
Dosage Form
-
Strength
5MG/SPRAY
Approval Date
2019-05-17
Regulatory Status
RX
Drug Name
NEUPRO
Product Number
1
Dosage Form
-
Strength
2MG/24HR
Approval Date
2007-05-09
Active Ingredient
ROTIGOTINE
Application Number
21829
Product Number
1
Dosage Form
-
Strength
2MG/24HR
Approval Date
2007-05-09
Regulatory Status
RX
Drug Name
NEUPRO
Product Number
2
Dosage Form
-
Strength
4MG/24HR
Approval Date
2007-05-09
Active Ingredient
ROTIGOTINE
Application Number
21829
Product Number
2
Dosage Form
-
Strength
4MG/24HR
Approval Date
2007-05-09
Regulatory Status
RX
Drug Name
NEUPRO
Product Number
3
Dosage Form
-
Strength
6MG/24HR
Approval Date
2007-05-09
Active Ingredient
ROTIGOTINE
Application Number
21829
Product Number
3
Dosage Form
-
Strength
6MG/24HR
Approval Date
2007-05-09
Regulatory Status
RX
Drug Name
NEUPRO
Product Number
4
Dosage Form
-
Strength
1MG/24HR
Approval Date
2012-04-02
Active Ingredient
ROTIGOTINE
Application Number
21829
Product Number
4
Dosage Form
-
Strength
1MG/24HR
Approval Date
2012-04-02
Regulatory Status
RX
Drug Name
NEUPRO
Product Number
5
Dosage Form
-
Strength
3MG/24HR
Approval Date
2012-04-02
Active Ingredient
ROTIGOTINE
Application Number
21829
Product Number
5
Dosage Form
-
Strength
3MG/24HR
Approval Date
2012-04-02
Regulatory Status
RX
Drug Name
NEUPRO
Product Number
6
Dosage Form
-
Strength
8MG/24HR
Approval Date
2012-04-02
Active Ingredient
ROTIGOTINE
Application Number
21829
Product Number
6
Dosage Form
-
Strength
8MG/24HR
Approval Date
2012-04-02
Regulatory Status
RX
Drug Name
NIRAVAM
Product Number
1
Dosage Form
-
Strength
0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-19
Active Ingredient
ALPRAZOLAM
Application Number
21726
Product Number
1
Dosage Form
-
Strength
0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-19
Regulatory Status
Discontinued
Drug Name
NIRAVAM
Product Number
2
Dosage Form
-
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-19
Active Ingredient
ALPRAZOLAM
Application Number
21726
Product Number
2
Dosage Form
-
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-19
Regulatory Status
Discontinued
Drug Name
NIRAVAM
Product Number
3
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-19
Active Ingredient
ALPRAZOLAM
Application Number
21726
Product Number
3
Dosage Form
-
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-19
Regulatory Status
Discontinued
Drug Name
NIRAVAM
Product Number
4
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-19
Active Ingredient
ALPRAZOLAM
Application Number
21726
Product Number
4
Dosage Form
-
Strength
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-01-19
Regulatory Status
Discontinued
Drug Name
PARCOPA
Product Number
1
Dosage Form
-
Strength
10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-08-27
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
76699
Product Number
1
Dosage Form
-
Strength
10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-08-27
Regulatory Status
Discontinued
Drug Name
PARCOPA
Product Number
2
Dosage Form
-
Strength
25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-08-27
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
76699
Product Number
2
Dosage Form
-
Strength
25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-08-27
Regulatory Status
Discontinued
Drug Name
PARCOPA
Product Number
3
Dosage Form
-
Strength
25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-08-27
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
76699
Product Number
3
Dosage Form
-
Strength
25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2004-08-27
Regulatory Status
Discontinued
Drug Name
PSEUDO-12
Product Number
1
Dosage Form
-
Strength
EQ 60MG HYDROCHLORIDE/5ML
Approval Date
1987-06-19
Active Ingredient
PSEUDOEPHEDRINE POLISTIREX
Application Number
19401
Product Number
1
Dosage Form
-
Strength
EQ 60MG HYDROCHLORIDE/5ML
Approval Date
1987-06-19
Regulatory Status
Discontinued
Drug Name
RYSTIGGO
Product Number
1
Dosage Form
-
Strength
280MG/2ML(140MG/ML)
Approval Date
-
Active Ingredient
ROZANOLIXIZUMAB-NOLI
Application Number
761286
Product Number
1
Dosage Form
-
Strength
280MG/2ML(140MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TUSSIONEX PENNKINETIC
Product Number
1
Dosage Form
-
Strength
EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-12-31
Active Ingredient
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Application Number
19111
Product Number
1
Dosage Form
-
Strength
EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-12-31
Regulatory Status
Discontinued
Drug Name
UNIRETIC
Product Number
1
Dosage Form
-
Strength
12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-06-27
Active Ingredient
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
Application Number
20729
Product Number
1
Dosage Form
-
Strength
12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-06-27
Regulatory Status
Discontinued
Drug Name
UNIRETIC
Product Number
2
Dosage Form
-
Strength
25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-06-27
Active Ingredient
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
Application Number
20729
Product Number
2
Dosage Form
-
Strength
25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-06-27
Regulatory Status
Discontinued
Drug Name
UNIRETIC
Product Number
3
Dosage Form
-
Strength
12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-02-14
Active Ingredient
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
Application Number
20729
Product Number
3
Dosage Form
-
Strength
12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-02-14
Regulatory Status
Discontinued
Drug Name
UNIVASC
Product Number
1
Dosage Form
-
Strength
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-04-19
Active Ingredient
MOEXIPRIL HYDROCHLORIDE
Application Number
20312
Product Number
1
Dosage Form
-
Strength
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-04-19
Regulatory Status
Discontinued
Drug Name
UNIVASC
Product Number
2
Dosage Form
-
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-04-19
Active Ingredient
MOEXIPRIL HYDROCHLORIDE
Application Number
20312
Product Number
2
Dosage Form
-
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-04-19
Regulatory Status
Discontinued
Drug Name
VIMPAT
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2008-10-28
Active Ingredient
LACOSAMIDE
Application Number
22253
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2008-10-28
Regulatory Status
RX
Drug Name
VIMPAT
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2008-10-28
Active Ingredient
LACOSAMIDE
Application Number
22253
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2008-10-28
Regulatory Status
RX
Drug Name
VIMPAT
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2008-10-28
Active Ingredient
LACOSAMIDE
Application Number
22253
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2008-10-28
Regulatory Status
RX
Drug Name
VIMPAT
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2008-10-28
Active Ingredient
LACOSAMIDE
Application Number
22253
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2008-10-28
Regulatory Status
RX
Drug Name
VIMPAT
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2008-10-28
Active Ingredient
LACOSAMIDE
Application Number
22254
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2008-10-28
Regulatory Status
RX
Drug Name
VIMPAT
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2010-04-20
Active Ingredient
LACOSAMIDE
Application Number
22255
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2010-04-20
Regulatory Status
RX
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
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
Drug Name
ZILBRYSQ
Product Number
2
Dosage Form
-
Strength
EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)
Approval Date
2023-10-17
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
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
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
78 total- Discontinued
- Unclassified
- RX
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Explore important FDA approved drug information available in the records above.
Drug Name
ALBUTEROL SULFATE
Application Number
73120
Product Number
1
Active Ingredient
ALBUTEROL SULFATE
Dosage Form
-
Strength
EQ 2MG BASE
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