FDA.reportPublic FDA data

Application 022544

Type
NDA
Sponsor
ALMATICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRALISEGABAPENTINTABLET;ORAL300MGYesYes
002GRALISEGABAPENTINTABLET;ORAL600MGYesYes
003GRALISEGABAPENTINTABLET;ORAL450MGYesNo
004GRALISEGABAPENTINTABLET;ORAL750MGYesNo
005GRALISEGABAPENTINTABLET;ORAL900MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13913-004GralisegabapentinDepomed, Inc.NDACurrent
13913-004GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-004GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-004GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-004GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-005GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-005GralisegabapentinDepomed, Inc.NDACurrent
13913-005GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-005GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-005GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-006GralisegabapentinDepomed, Inc.NDACurrent
13913-006GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
13913-006GralisegabapentinAssertio Therapeutics, Inc.NDACurrent
50436-1262GralisegabapentinUnit Dose ServicesNDACurrent
52427-803GralisegabapentinAlmatica Pharma LLCNDACurrent
52427-803GralisegabapentinAlmatica Pharma LLCNDACurrent
52427-803GralisegabapentinAlmatica Pharma LLCNDACurrent
52427-806GralisegabapentinAlmatica Pharma LLCNDACurrent
52427-806GralisegabapentinAlmatica Pharma LLCNDACurrent
52427-806GralisegabapentinAlmatica Pharma LLCNDACurrent
52427-815GralisegabapentinAlmatica Pharma LLCNDACurrent
52427-815GralisegabapentinAlmatica Pharma LLCNDACurrent
52427-815GralisegabapentinAlmatica Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82106SUPPL 2025-05-01
82058SUPPL 2025-04-29
82057SUPPL 2025-04-29
74054SUPPL 2023-06-13
74060SUPPL 2023-04-26
72415SUPPL2022-10-19
68948SUPPL2021-10-08
68916SUPPL2021-10-08
62531SUPPL2020-04-10
62428SUPPL2020-04-03
17693SUPPL2013-04-01
7518SUPPL2012-08-10
38828SUPPL2012-08-09
29845SUPPL2012-02-03
17692SUPPL2012-02-01
44775ORIG2011-10-18
22051ORIG2011-10-18
7517SUPPL2011-07-05
38827SUPPL2011-06-30
29844SUPPL2011-05-03
23413ORIG2011-03-01
38826ORIG2011-02-04
7516ORIG2011-02-03