Application 022038

Type: NDA
Sponsor: VERTICAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIVIGEL	ESTRADIOL	GEL;TRANSDERMAL	0.1%	Yes	Yes
002	DIVIGEL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (0.5GM/PACKET)	Yes	Yes
003	DIVIGEL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (1GM/PACKET)	Yes	Yes
004	DIVIGEL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (0.75GM/PACKET)	Yes	Yes
005	DIVIGEL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (1.25GM/PACKET)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022038-001	DIVIGEL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04
N022038-002	DIVIGEL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04
N022038-003	DIVIGEL	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04
N022038-004	DIVIGEL	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17
N022038-005	DIVIGEL	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N022038-001	AB
N022038-002	AB
N022038-003	AB
N022038-004	AB
N022038-005	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022038-001	DIVIGEL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022038-002	DIVIGEL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022038-003	DIVIGEL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022038-004	DIVIGEL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022038-005	DIVIGEL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022038-001	DIVIGEL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022038-002	DIVIGEL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022038-003	DIVIGEL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022038-004	DIVIGEL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022038-005	DIVIGEL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-001	DIVIGEL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-002	DIVIGEL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-003	DIVIGEL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-004	DIVIGEL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-005	DIVIGEL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022038-001	DIVIGEL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022038-002	DIVIGEL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022038-003	DIVIGEL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022038-004	DIVIGEL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022038-005	DIVIGEL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-001	DIVIGEL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-002	DIVIGEL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-003	DIVIGEL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-004	DIVIGEL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-005	DIVIGEL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-001	DIVIGEL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-002	DIVIGEL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-003	DIVIGEL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-004	DIVIGEL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-005	DIVIGEL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-001	DIVIGEL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-002	DIVIGEL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-003	DIVIGEL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-004	DIVIGEL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-005	DIVIGEL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-001	DIVIGEL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-002	DIVIGEL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-003	DIVIGEL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2007-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-004	DIVIGEL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2018-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-005	DIVIGEL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	RLD, RS	2019-12-12	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022038-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022038-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022038-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022038-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022038-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022038-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022038-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022038-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022038-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022038-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022038-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022038-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022038-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022038-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022038-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022038-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022038-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022038-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022038-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022038-005	AB	1	`2680178bc6a6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Trigen Laboratories, LLC	e84ad638-6768-41aa-b2b8-e2514ef63881	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022038 application number: NDA022038 ndc (product): 13811-091 ndc (product): 13811-092 ndc (product): 13811-090 ndc (product): 13811-094 ndc (product): 13811-093
DIVIGEL	ESTRADIOL	Vertical Pharmaceuticals, LLC	59e610dc-883e-4f07-9ec6-a5841b0bf9fb	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022038 application number: NDA022038 ndc (product): 68025-086 ndc (product): 68025-066 ndc (product): 68025-067 ndc (product): 68025-083 ndc (product): 68025-065

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-090	Estradiol	Estradiol	Trigen Laboratories, LLC	NDA	Current
13811-091	Estradiol	Estradiol	Trigen Laboratories, LLC	NDA	Current
13811-092	Estradiol	Estradiol	Trigen Laboratories, LLC	NDA	Current
13811-093	Estradiol	Estradiol	Trigen Laboratories, LLC	NDA	Current
13811-094	Estradiol	Estradiol	Trigen Laboratories, LLC	NDA	Current
68025-065	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-065	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-065	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-065	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-065	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-065	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-066	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-066	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-066	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-066	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-066	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-066	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-067	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-067	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-067	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-067	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-067	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-067	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-083	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-083	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-083	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-083	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-083	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-083	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-086	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-086	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-086	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-086	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current
68025-086	DIVIGEL	estradiol	Vertical Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82075	SUPPL	2026-04-14
85028	SUPPL	2026-02-12
85021	SUPPL	2026-02-12
82125	SUPPL	2025-05-01
77568	SUPPL	2024-02-20
77545	SUPPL	2024-02-16
74363	SUPPL	2023-05-24
74361	SUPPL	2023-05-24
61274	SUPPL	2019-12-13
61273	SUPPL	2019-12-13
61262	SUPPL	2019-12-13
61261	SUPPL	2019-12-13
55258	SUPPL	2018-08-21
55215	SUPPL	2018-08-20
50268	SUPPL	2017-11-02
38122	SUPPL	2012-06-06
6742	SUPPL	2012-05-31
42397	ORIG	2009-12-30
24236	ORIG	2009-12-30
29124	ORIG	2007-06-07
16812	ORIG	2007-06-07