Application 040326

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRADIOL	ESTRADIOL	TABLET;ORAL	0.5MG	No	No
002	ESTRADIOL	ESTRADIOL	TABLET;ORAL	1MG	No	No
003	ESTRADIOL	ESTRADIOL	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040326-001	ESTRADIOL	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21
A040326-002	ESTRADIOL	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21
A040326-003	ESTRADIOL	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040326-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040326-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040326-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040326-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040326-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040326-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040326-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040326-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040326-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040326-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040326-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040326-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040326-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040326-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040326-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040326-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040326-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040326-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040326-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040326-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040326-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040326-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040326-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040326-003	AB	1	`ea99ee380514…`

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 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minivelle	ESTRADIOL	Noven Therapeutics, LLC	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Redpharm Drug	5718f042-e8c0-b721-e063-6294a90a5bef	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	Redpharm Drug	546c168d-2a85-69b6-e063-6294a90a22ac	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	e6bf2abc-71ae-4e79-a37b-164c98ba746a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	34bcec8e-c7a6-4a1c-9884-4d4efe024bb9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	REMEDYREPACK INC.	41f7a56c-4ce3-4cc6-803e-1ff662efef90	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	REMEDYREPACK INC.	59a4b68d-a507-4809-a0c8-fd9799986d12	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	ba935918-39b3-4b56-bd83-78a29958e6d8	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	1c38f0d0-a360-4b66-bc0e-7d54e92465a1	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	REMEDYREPACK INC.	477cb52e-8ce2-491f-94a0-869ff60bf7ab	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	eacafc4a-2fa8-403d-8df7-2bc92d73a54f	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	ee5460ab-27e7-487a-a89c-bf8735399be6	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	REMEDYREPACK INC.	774ee81b-8e29-46af-ab12-7157f63b443b	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
EstroGel	ESTRADIOL	ASCEND Therapeutics US, LLC	762ac371-bb8b-47e7-b48f-e80d452c9dd4	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	afd70875-0a93-40a7-842e-f4359818c2d9	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL GEL 0.1%	Xiromed, LLC	1a46efe6-21b9-3f0f-90b9-59f279ef51df	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol
ESTRADIOL	ESTRADIOL	Encube Ethicals, Inc.	54f108d6-ddd2-4276-8508-2c8e16a65fb2	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol Gel	ESTRADIOL	Encube Ethicals, Inc.	d4a3606f-83b2-45df-bc77-faebfa796f9a	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estring	ESTRADIOL	Pfizer Laboratories Div Pfizer Inc	110b9865-5a07-4d45-b560-e89947f12600	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-0073	Estradiol	estradiol	KAISER FOUNDATION HOSPITA	ANDA	Current
0378-1452	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1452	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1454	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1454	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1458	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1458	Estradiol	estradiol	Mylan Pharmaceuticals Inc.	ANDA	Current
50090-2624	Estradiol	estradiol	A-S Medication Solutions	ANDA	Current
55289-603	Estradiol	estradiol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-603	Estradiol	estradiol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-603	Estradiol	estradiol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-761	Estradiol	estradiol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-761	Estradiol	estradiol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-761	Estradiol	estradiol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
38883	ORIG	2004-06-03
22126	ORIG	2003-07-31
29928	ORIG	1999-04-21