Application Information

This drug has been submitted to the FDA under the reference 071260/001.

Names and composition

"BACLOFEN" is the commercial name of a drug composed of BACLOFEN.
It belongs to the class Skeletal muscle relaxants and is used in Muscle spasm (Musculoskeletal Disorders)

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
071260/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
071261/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
072234/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
072235/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
072824/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
072825/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
073043/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
073044/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
073092/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
073093/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
074584/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
074584/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
074698/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
074698/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077068/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077088/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077089/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077121/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077121/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077156/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077181/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077241/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077241/002 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077862/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077971/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077971/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077984/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
078401/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
078401/002 BACLOFEN BACLOFEN TABLET/ORAL 10MG
078504/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
090334/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
090334/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
091193/001 BACLOFEN BACLOFEN INJECTABLE/INTRATHECAL 0.05MG per ML
091193/002 BACLOFEN BACLOFEN INJECTABLE/INTRATHECAL 0.5MG per ML
091193/003 BACLOFEN BACLOFEN INJECTABLE/INTRATHECAL 2MG per ML

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
017851/001 LIORESAL BACLOFEN TABLET/ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
017851/003 LIORESAL BACLOFEN TABLET/ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020075/001 LIORESAL BACLOFEN INJECTABLE/INTRATHECAL 0.5MG per ML
020075/002 LIORESAL BACLOFEN INJECTABLE/INTRATHECAL 2MG per ML
020075/003 LIORESAL BACLOFEN INJECTABLE/INTRATHECAL 0.05MG per ML
021589/001 KEMSTRO BACLOFEN TABLET, ORALLY DISINTEGRATING/ORAL 10MG
021589/002 KEMSTRO BACLOFEN TABLET, ORALLY DISINTEGRATING/ORAL 20MG
022462/001 GABLOFEN BACLOFEN INJECTABLE/INTRATHECAL 0.05MG per ML
022462/002 GABLOFEN BACLOFEN INJECTABLE/INTRATHECAL 0.5MG per ML
022462/003 GABLOFEN BACLOFEN INJECTABLE/INTRATHECAL 2MG per ML
022462/004 GABLOFEN BACLOFEN INJECTABLE/INTRATHECAL 1MG per ML
071260/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
071261/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
072234/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
072235/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
072824/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
072825/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
073043/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
073044/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
073092/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
073093/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
074584/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
074584/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
074698/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
074698/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077068/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077088/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077089/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077121/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077121/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077156/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077181/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077241/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077241/002 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077862/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077971/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
077971/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
077984/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
078401/001 BACLOFEN BACLOFEN TABLET/ORAL 20MG
078401/002 BACLOFEN BACLOFEN TABLET/ORAL 10MG
078504/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
090334/001 BACLOFEN BACLOFEN TABLET/ORAL 10MG
090334/002 BACLOFEN BACLOFEN TABLET/ORAL 20MG
091193/001 BACLOFEN BACLOFEN INJECTABLE/INTRATHECAL 0.05MG per ML
091193/002 BACLOFEN BACLOFEN INJECTABLE/INTRATHECAL 0.5MG per ML
091193/003 BACLOFEN BACLOFEN INJECTABLE/INTRATHECAL 2MG per ML

Manufacturers

Manufacturer name
Novartis Pharmaceuticals UK Ltd
Chemidex Pharma Ltd

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