FDA.reportPublic FDA data

Application 020075

Type
NDA
Sponsor
SAOL THERAPS RES LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIORESALBACLOFENINJECTABLE;INTRATHECAL0.5MG/MLYesYes
002LIORESALBACLOFENINJECTABLE;INTRATHECAL2MG/MLYesYes
003LIORESALBACLOFENINJECTABLE;INTRATHECAL0.05MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58281-560LioresalbaclofenMedtronic NeuromodulationNDACurrent
58281-561LioresalbaclofenMedtronic NeuromodulationNDACurrent
58281-562LioresalbaclofenMedtronic NeuromodulationNDACurrent
58281-563LioresalbaclofenMedtronic NeuromodulationNDACurrent
70121-2501Lioresal (baclofen)baclofenAmneal Pharmaceuticals LLCNDACurrent
70121-2502Lioresal (baclofen)baclofenAmneal Pharmaceuticals LLCNDACurrent
70121-2503Lioresal (baclofen)baclofenAmneal Pharmaceuticals LLCNDACurrent
70121-2504Lioresal (baclofen)baclofenAmneal Pharmaceuticals LLCNDACurrent
70257-560Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-560Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-560Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-561Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-561Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-561Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-562Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-562Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-562Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-563Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-563Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent
70257-563Lioresal (baclofen)baclofenSaol Therapeutics Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70699SUPPL2022-04-05
70615SUPPL2022-03-28
57311SUPPL2019-01-22
57235SUPPL2019-01-17
45597SUPPL2016-10-06
45461SUPPL2016-10-04
1990SUPPL2014-11-21
34238SUPPL2013-11-22
21110SUPPL2013-11-20
34237SUPPL2013-03-08
12180SUPPL2011-11-16
1989SUPPL2011-11-16
34236SUPPL2011-03-29
21109SUPPL2011-03-29
1988SUPPL2003-05-30
21108SUPPL2003-01-17
1987SUPPL2002-11-20
21107SUPPL2002-03-06
1986SUPPL2002-03-06