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Phenylbutazone

Generic Name
Phenylbutazone
Drug Type
Small Molecule
Chemical Formula
C19H20N2O2
CAS Number
50-33-9
Unique Ingredient Identifier
GN5P7K3T8S

Overview

A drug that has anti-inflammatory, antipyretic, and analgesic activities. It is especially effective in the treatment of ankylosing spondylitis. It also is useful in rheumatoid arthritis and Reiter's syndrome (investigational indication). Although phenylbutazone is effective in gouty arthritis, risk/benefit considerations indicate that this drug should not be employed for this disease. (From AMA Drug Evaluations Annual, 1994, p1822)

Indication

For the treatment of backache and ankylosing spondylitis

Associated Conditions

  • Inflammation
  • Pain
  • Arthritic pain

Clinical Trials

Title
Posted
Study ID
Phase
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Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

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NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ALKA PHENYL TAB
00430900
Tablet - Oral
100 MG / TAB
12/31/1978
PHENYLONE PLUS TAB
medic laboratory ltée
00432954
Tablet - Oral
100 MG / TAB
12/31/1978
NOVO-BUTAZONE TAB 100MG
novopharm limited
00021660
Tablet - Oral
100 MG
12/31/1976
APO PHENYLBUTAZONE TAB 100MG
00312789
Tablet - Oral
100 MG
12/31/1976
ALKA PHENYLBUTAZONE TAB
PRO DOC LIMITEE
00291854
Tablet - Oral
100 MG / TAB
12/31/1974

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
DOCTOFRIL CREMA
Laboratorios Asociados Nupel S.L.
47135
CREMA
Sin Receta
Not Commercialized
DERSINDOL EXTRA
Dermogen-Farma S.A.
49472
CREMA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

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Company
License Number
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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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License Number
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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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