FDA.reportPublic FDA data

Application 022399

Type
NDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HORIZANTGABAPENTIN ENACARBILTABLET, EXTENDED RELEASE;ORAL600MGYesYes
002HORIZANTGABAPENTIN ENACARBILTABLET, EXTENDED RELEASE;ORAL300MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53451-0101Horizantgabapentin enacarbilArbor PharmaceuticalsNDACurrent
53451-0101Horizantgabapentin enacarbilArbor PharmaceuticalsNDACurrent
53451-0101Horizantgabapentin enacarbilAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
53451-0101Horizantgabapentin enacarbilArbor PharmaceuticalsNDACurrent
53451-0101Horizantgabapentin enacarbilArbor PharmaceuticalsNDACurrent
53451-0103Horizantgabapentin enacarbilArbor PharmaceuticalsNDACurrent
53451-0103Horizantgabapentin enacarbilArbor PharmaceuticalsNDACurrent
53451-0103Horizantgabapentin enacarbilAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
53451-0103Horizantgabapentin enacarbilArbor PharmaceuticalsNDACurrent
53451-0103Horizantgabapentin enacarbilArbor PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82107SUPPL 2025-05-01
82056SUPPL 2025-04-29
82055SUPPL 2025-04-25
62612SUPPL2020-04-20
62611SUPPL2020-04-20
62596SUPPL2020-04-20
62529SUPPL2020-04-10
62429SUPPL2020-04-03
60742SUPPL2019-10-31
45791SUPPL2016-11-02
17313SUPPL2013-05-09
29677SUPPL2013-05-07
38654SUPPL2013-04-01
7323SUPPL2013-03-29
38656SUPPL2012-12-28
38655SUPPL2012-12-28
29676SUPPL2012-12-27
7324SUPPL2012-12-27
17311SUPPL2012-06-11
29675SUPPL2012-06-08
7322SUPPL2012-04-23
17312SUPPL2012-04-20
44747ORIG2011-05-16
22011ORIG2011-05-16
7321ORIG2011-04-11
38653ORIG2011-04-07
23392ORIG2011-04-07