Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Lioresal, baclofen, Injectable; Intrathecal, Medtronic, Manufacturing Change or Addition | Gablofen, baclofen, Injectable; Intrathecal, Cns Theraps Inc, Manufacturing Change or Addition | Lioresal, baclofen, Injectable; Intrathecal, Medtronic, Manufacturing Change or Addition ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2013 Betterchem.com