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GABLOFEN (nda022462)- (0.05MG/ML,0.5MG/ML,1MG/ML,2MG/ML)

BACLOFEN PIRAMAL CRITICAL
0.05MG/ML,0.5MG/ML,1MG/ML,2MG/ML
No Yes
Expired Expired
None None
None No
GABLOFEN is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above.  GABLOFEN should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses.
3 0 3
Total Other Developers 5
Drugs with Suitability No
0.05MG/ML ** ** - - -
0.5MG/ML ** ** - - -
1MG/ML ** ** - - -
2MG/ML ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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