FDA.reportPublic FDA data

Application 022006

Type
NDA
Sponsor
LUNDBECK PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SABRILVIGABATRINFOR SOLUTION;ORAL500MG/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent
67386-211SABRILvigabatrinLundbeck Pharmaceuticals LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85436SUPPL 2026-03-20
79608SUPPL 2024-09-16
72320SUPPL2022-10-13
69061SUPPL2021-10-21
69050SUPPL2021-10-21
69049SUPPL2021-10-21
64828SUPPL2020-10-05
61699SUPPL2020-01-27
61671SUPPL2020-01-27
59995SUPPL2019-09-13
59555SUPPL2019-08-02
59554SUPPL2019-08-02
59541SUPPL2019-08-01
58911SUPPL2019-06-03
55321SUPPL2018-08-27
55281SUPPL2018-08-23
55280SUPPL2018-08-23
50214SUPPL2017-10-30
48225SUPPL2017-05-02
48196SUPPL2017-05-02
38069SUPPL2016-06-27
6667SUPPL2016-06-23
16751SUPPL2015-11-04
6668SUPPL2015-11-04
38070SUPPL2015-09-23
29053SUPPL2015-09-22
38068SUPPL2014-04-04
6666SUPPL2014-04-04
38067SUPPL2013-10-31
16750SUPPL2013-10-31
16749SUPPL2013-10-31
29052SUPPL2013-10-29
6665SUPPL2013-10-29
6664SUPPL2013-10-29
16748SUPPL2012-12-14
24013ORIG2011-02-02
16747SUPPL2011-01-25
29051SUPPL2011-01-24
24231ORIG2009-10-16
21901ORIG2009-10-16
29050ORIG2009-08-26
53554ORIG1900-01-01
53553ORIG1900-01-01
53552ORIG1900-01-01