FDA.reportPublic FDA data

Application 022038

Type
NDA
Sponsor
VERTICAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIVIGELESTRADIOLGEL;TRANSDERMAL0.1%YesYes
002DIVIGELESTRADIOLGEL;TRANSDERMAL0.1% (0.5GM/PACKET)YesYes
003DIVIGELESTRADIOLGEL;TRANSDERMAL0.1% (1GM/PACKET)YesYes
004DIVIGELESTRADIOLGEL;TRANSDERMAL0.1% (0.75GM/PACKET)YesYes
005DIVIGELESTRADIOLGEL;TRANSDERMAL0.1% (1.25GM/PACKET)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-090EstradiolEstradiolTrigen Laboratories, LLCNDACurrent
13811-091EstradiolEstradiolTrigen Laboratories, LLCNDACurrent
13811-092EstradiolEstradiolTrigen Laboratories, LLCNDACurrent
13811-093EstradiolEstradiolTrigen Laboratories, LLCNDACurrent
13811-094EstradiolEstradiolTrigen Laboratories, LLCNDACurrent
68025-065DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-065DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-065DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-065DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-065DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-065DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-066DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-066DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-066DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-066DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-066DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-066DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-067DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-067DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-067DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-067DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-067DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-067DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-083DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-083DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-083DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-083DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-083DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-083DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-086DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-086DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-086DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-086DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent
68025-086DIVIGELestradiolVertical Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82075SUPPL 2026-04-14
85028SUPPL 2026-02-12
85021SUPPL 2026-02-12
82125SUPPL 2025-05-01
77568SUPPL 2024-02-20
77545SUPPL 2024-02-16
74363SUPPL 2023-05-24
74361SUPPL 2023-05-24
61274SUPPL2019-12-13
61273SUPPL2019-12-13
61262SUPPL2019-12-13
61261SUPPL2019-12-13
55258SUPPL2018-08-21
55215SUPPL2018-08-20
50268SUPPL2017-11-02
38122SUPPL2012-06-06
6742SUPPL2012-05-31
42397ORIG2009-12-30
24236ORIG2009-12-30
29124ORIG2007-06-07
16812ORIG2007-06-07