FDA.reportPublic FDA data

Application 203993

Type
NDA
Sponsor
LUNDBECK PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONFICLOBAZAMSUSPENSION;ORAL2.5MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67386-313OnficlobazamLundbeck Pharmaceuticals LLCNDACurrent
67386-313OnficlobazamLundbeck Pharmaceuticals LLCNDACurrent
67386-313OnficlobazamLundbeck Pharmaceuticals LLCNDACurrent
67386-313OnficlobazamLundbeck Pharmaceuticals LLCNDACurrent
67386-313OnficlobazamLundbeck Pharmaceuticals LLCNDACurrent
67386-313OnficlobazamLundbeck Pharmaceuticals LLCNDACurrent
67386-313OnficlobazamLundbeck Pharmaceuticals LLCNDACurrent
67386-313OnficlobazamLundbeck Pharmaceuticals LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77823SUPPL 2024-03-13
77807SUPPL 2024-03-13
77806SUPPL 2024-03-13
73208SUPPL2023-01-17
73207SUPPL2023-01-17
73183SUPPL2023-01-17
66153SUPPL2021-02-09
66152SUPPL2021-02-09
66125SUPPL2021-02-09
54656SUPPL2018-06-21
54655SUPPL2018-06-21
54630SUPPL2018-06-20
46473SUPPL2016-12-22
46286SUPPL2016-12-20
19511SUPPL2015-05-12
32488SUPPL2014-12-11
10269SUPPL2013-11-26
40338SUPPL2013-11-22
44892ORIG2013-07-08
43450ORIG2013-07-08
10268ORIG2012-12-20
19510ORIG2012-12-18