Application 217863

Type: ANDA
Sponsor: SOLARIS PHARMA CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRADIOL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (0.25GM/PACKET)	No	No
002	ESTRADIOL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (0.5GM/PACKET)	No	No
003	ESTRADIOL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (0.75GM/PACKET)	No	No
004	ESTRADIOL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (1GM/PACKET)	No	No
005	ESTRADIOL	ESTRADIOL	GEL;TRANSDERMAL	0.1% (1.25GM/PACKET)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A217863-001	ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12
A217863-002	ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12
A217863-003	ESTRADIOL	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12
A217863-004	ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12
A217863-005	ESTRADIOL	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217863-001	AB
A217863-002	AB
A217863-003	AB
A217863-004	AB
A217863-005	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 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217863-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217863-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217863-003	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217863-004	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217863-005	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217863-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217863-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217863-003	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217863-004	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217863-005	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217863-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217863-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217863-003	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217863-004	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217863-005	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-003	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-004	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-005	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217863-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217863-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217863-003	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217863-004	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217863-005	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-003	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-004	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-005	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-003	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-004	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-005	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-001	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-002	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-003	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-004	ESTRADIOL	0.1% (1GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-005	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL / TRANSDERMAL	AB	2024-07-12	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217863-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217863-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217863-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217863-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217863-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217863-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217863-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217863-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217863-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217863-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217863-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217863-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217863-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217863-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217863-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217863-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217863-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217863-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217863-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217863-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217863-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217863-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217863-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217863-005	AB	1	`03ed91905a0d…`

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 4 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	f4efb0bf-b96f-4e20-a0f2-0806ab92b2d4	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Coupler LLC	37c99e4d-fb0d-0e6e-e063-6394a90a69c8	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	d28bec8f-762e-4f05-a20d-96a42970d6a7	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	NorthStar Rx LLC	0c8a07a4-5762-eaf4-e063-6394a90a54ff	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol Vaginal Cream	ESTRADIOL	Prasco Laboratories	c895ac14-5dbd-4201-bf3e-ba7c38a4e994	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	American Health Packaging	265a1ee1-f314-4324-a2e1-0120a9a00a20	2025-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Preferred Pharmaceuticals Inc.	9956a196-fefd-4766-a225-e154fbd3aeff	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	3e84e3e7-4b50-407f-a215-45363b541384	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Preferred Pharmaceuticals Inc.	72fbd5a8-9c34-4790-84ed-79f5bd3ae0f0	2025-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	fad3813c-9495-416b-9789-623d5758b4e3	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	cf1ebc1d-8f3c-4468-b565-f0da69986e7c	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	bfc1beb9-1ade-446e-97dd-55b41c2fa851	2025-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	d0d1c2c8-b175-4250-9343-d7db65b72e8f	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	dd7d2d2a-e76b-7dfe-e053-2995a90a790a	2025-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	aa396e57-0a93-49cc-82e5-cd35c987bb0b	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	8788ddd1-36a6-416a-b527-75eb41de2808	2025-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	NuCare Pharmaceuticals, Inc.	2e5a4d78-6683-4fb8-e063-6294a90a49e7	2025-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	487ce40e-1f13-4497-994a-c5d91b87b6cc	2025-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Vagifem	ESTRADIOL	Novo Nordisk	e5ad3cf6-dd96-4e64-af21-c1eee38d0b88	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Direct_Rx	032135ee-7bc9-5cdf-e063-6394a90ad9a2	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.