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Sulbactam
Unasyn, Xacduro (sulbactam) is a small molecule pharmaceutical. Sulbactam was first approved as Unasyn on 1986-12-31. It is used to treat acinetobacter infections, bacterial skin diseases, escherichia coli infections, intraabdominal infections, and klebsiella infections amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Combinations
Unasyn, Xacduro (generic drugs available since 1988-11-23)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ampicillin sodium
+
Sulbactam sodium
Tradename
Company
Number
Date
Products
UNASYNMylanN-050608 RX1986-12-31
3 products, RLD, RS
Show 1 discontinued
Durlobactam sodium
+
Durlobactam sodium
+
Sulbactam sodium
Tradename
Company
Number
Date
Products
XACDURO (COPACKAGED)Entasis TherapeuticsN-216974 RX2023-05-24
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
unasynNew Drug Application2023-03-29
xacduroNew Drug Application2023-06-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acinetobacter infectionsEFO_1000792D000151—
bacterial skin diseases—D017192—
escherichia coli infectionsEFO_1001318D004927B96.20
intraabdominal infections—D059413—
klebsiella infectionsEFO_1001353D007710—
proteus infectionsEFO_1001130D011512—
staphylococcal infections—D013203A49.01
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01C: Beta-lactam antibacterials, penicillins
— J01CG: Beta-lactamase inhibitors, systemic penicillins
— J01CG01: Sulbactam
HCPCS
Code
Description
J0295
Injection, ampicillin sodium/sulbactam sodium, per 1.5 gm
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyspepsiaD004415EFO_0008533K30———112
Ventilator-associated pneumoniaD053717EFO_1001865J95.851———1—1
GastritisD005756EFO_0000217K29.7———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Head and neck neoplasmsD006258——2——2
MucositisD052016EFO_1001898——1——1
Esophageal neoplasmsD004938C15——1——1
Mediastinal neoplasmsD008479C38.3——1——1
Oropharyngeal neoplasmsD009959——1——1
Laryngeal neoplasmsD007822EFO_0003817C32——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HerpanginaD006557EFO_0007306B08.5—1———1
Foot and mouth disease handD006232EFO_0007294B08.4—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Eosinophilic esophagitisD057765EFO_0004232K20.01————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastroesophageal refluxD005764EFO_0003948K21————22
Vestibulocochlear nerve diseasesD000160H93.3————11
Electric stimulationD004558————11
PainD010146EFO_0003843R52————11
AnxietyD001007EFO_0005230F41.1————11
Rotator cuff injuriesD000070636M75.1————11
Body weight changesD001836————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSULBACTAM
INNsulbactam
Description
Sulbactam is a member of penicillanic acids.
Classification
Small molecule
Drug classbeta-lactamase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC1(C)[C@H](C(=O)O)N2C(=O)C[C@H]2S1(=O)=O
Identifiers
PDB—
CAS-ID68373-14-8
RxCUI10167
ChEMBL IDCHEMBL403
ChEBI ID9321
PubChem CID130313
DrugBankDB09324
UNII IDS4TF6I2330 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,739 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1,667 adverse events reported
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