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FDA Warning Letters citing this API.

 

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FDA Approval Activities for this Drug…

Baclofen Injection, 0.05mg/ml, Medtronic Neurological NDA 20-075/S-019 Lioresal Intrathecal (Baclofen) Injection, Medtronic NDA 20-075/S20 5/8/03 7/9/03 Lioresal (Baclofen) Injection, Medtronic Drug Delivery NDA 20-075/S17 11/20/02 12/6/02 Lioresal (Baclofen) Injection, Medtronic Drug Delivery NDA 20-075/S14 & 16 Kemstro (Baclofen) Tablets, Schwarz Pharma BACLOFEN Intrathecal 0.05MG/ML LIORESAL MEDTRONIC 020075 BACLOFEN Intrathecal 0.5MG/ML LIORESAL MEDTRONIC 020075 BACLOFEN Intrathecal 2MG/ML LIORESAL MEDTRONIC 072234 BACLOFEN Tablet; 10MG BACLOFEN Ivax 072235 BACLOFEN Tablet; 20MG BACLOFEN Ivax 074584 BACLOFEN Tablet; 10MG BACLOFEN USL 074584 BACLOFEN Tablet; 20MG BACLOFEN USL 074698 BACLOFEN Tablet; 10MG BACLOFEN Watson 072824 BACLOFEN Tablet; 10MG BACLOFEN Watson 073092 BACLOFEN Tablet; 10MG BACLOFEN Watson 073093 BACLOFEN Tablet; 20MG BACLOFEN Watson 072825 BACLOFEN Tablet; 20MG BACLOFEN Watson 074698 BACLOFEN Tablet; 20MG BACLOFEN Watson

For the most up-to-date approval information, please locate this API using the drug index.


 

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