FDA.reportPublic FDA data

Application 022462

Type
NDA
Sponsor
PIRAMAL CRITICAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABLOFENBACLOFENINJECTABLE;INTRATHECAL0.05MG/MLNoNo
002GABLOFENBACLOFENINJECTABLE;INTRATHECAL0.5MG/MLNoNo
003GABLOFENBACLOFENINJECTABLE;INTRATHECAL2MG/MLNoNo
004GABLOFENBACLOFENINJECTABLE;INTRATHECAL1MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45945-156GablofenbaclofenMallinckrodt Inc (Brand Pharmaceuticals)NDACurrent
45945-157GablofenbaclofenMallinckrodt Inc (Brand Pharmaceuticals)NDACurrent
66794-151GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-151GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-151GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-151GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-151GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-151GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-151GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-151GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-155GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-155GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-155GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-155GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-155GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-155GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-155GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-155GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-156GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-156GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-156GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-156GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-156GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-156GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-156GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-156GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-157GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-157GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-157GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-157GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-157GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-157GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-157GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent
66794-157GablofenBaclofen InjectionPiramal Critical Care IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73671SUPPL 2023-03-03
71190SUPPL2022-06-01
71185SUPPL2022-06-01
67118SUPPL2021-04-20
61423SUPPL2019-12-23
61410SUPPL2019-12-23
57402SUPPL2019-02-01
38733SUPPL2015-02-12
7418SUPPL2015-02-12
24314ORIG2011-03-07
22027ORIG2011-03-07
29750ORIG2010-11-29
17604ORIG2010-11-26