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 43.

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040326-001	ESTRADIOL	0.5MG	TABLET / ORAL	1999-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040326-002	ESTRADIOL	1MG	TABLET / ORAL	1999-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040326-003	ESTRADIOL	2MG	TABLET / ORAL	1999-04-21	`caaa826d4ba7…`
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…`

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 3 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Northwind Health Company, LLC	106b92da-334c-542f-e063-6394a90aa65b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Northwind Health Company, LLC	0a1e744c-7926-0e0c-e063-6294a90a80d0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Northwind Health Company, LLC	f6caf47a-1917-c493-e053-6394a90af63e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Northwind Health Company, LLC	f6cb38ab-fdff-9c07-e053-6294a90ad59a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Northwind Health Company, LLC	f76aff99-f415-9045-e053-6294a90afd51	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c94738ff-dece-4fb6-bb44-4f8832a45f38	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Alvogen Inc.	0178a92c-62b1-d5cf-cf54-2c85af88a74a	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	NorthStar Rx LLC	1c2cd11a-e010-20b2-e063-6294a90a52d5	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	Padagis Israel Pharmaceuticals Ltd	f76232ed-b109-43d1-bf2e-d41b6420c37d	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	ff3bcb07-f6fe-4582-948a-21dbf1e55f55	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL VAGINAL INSERTS	ESTRADIOL	Glenmark Pharmaceuticals Inc., USA	86620f6c-fd02-40df-98d5-3048dcd92c37	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	f3806b5d-ebd6-43b4-adfa-a1fe86d80642	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	f3a77482-f490-f350-e053-2a95a90ad8cb	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL VAGINAL INSERTS	ESTRADIOL	Aurobindo Pharma Limited	6247e329-e20e-4ea5-9cc1-b593bd494577	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	c8ac2e13-58d5-4e70-e053-2995a90aff04	2025-09-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL VAGINAL INSERTS	ESTRADIOL	NorthStar Rx LLC	ad203bfd-28da-45a3-b9c0-7f886eb03634	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	e962e36d-5d84-4b39-9bdf-e5f9a264b82a	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	13f9c41b-417c-45e4-9a59-baf774fca78d	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL VAGINAL	ESTRADIOL	Encube Ethicals, Inc.	1c61e837-4196-4b4d-9545-96b2d7c66f13	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	e7e6da3b-8485-1382-61c9-e9b369018b98	2025-06-23	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.

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