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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 | Baclofen Tablets, Alphapharm, Approval | Baclofen Tablets, Alphapharm, Approval | Baclofen Tablets, Lannett Holdings, Approval | Baclofen Tablets, Caraco Pharma, Approval | Baclofen Tablets, Lannett Holdings, ApprovalBaclofen 10mg Tablets, Impax Labs, Approval | Baclofen 20mg Tablets, Impax Labs, Approval | Baclofen 20mg Tablets, Actavis Totowa, Approval | Baclofen 10mg Tablets, Actavis Totowa, Approval | Baclofen Tablets, Northstar Healthcare Holdings Ltd., Approval | Baclofen Tablets, Matrix Laboratories Ltd., Approval | Gablofen (baclofen) Injection, CNS Therapeutics, Inc., Approval | Lioresal (baclofen) Intrathecal Injection, Medtronic, Inc., Labeling Revision | Lioresal (baclofen) Intrathecal Injection, Medtronic Neuromodulation, Labeling Revision
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