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 7 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
YUVAFEM	ESTRADIOL	Amneal Pharmaceuticals LLC	30c7f6ba-7a9e-4853-b3e4-e00a46560224	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals of New York LLC	094830ee-1b1c-4cf7-8a39-427dfd56f9c9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	8cb31c7c-fba8-4201-833d-844ea1a8a4de	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	684850eb-d889-4370-a0a7-4a5c3113266a	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: estradiol generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	db4696da-7820-4b2b-97b4-fb05b1208020	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	839fe7ae-6835-4d6a-b6b1-ca7f062caa4f	2024-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Sandoz Inc	c4da6de7-9ab1-4fcf-88f3-fe785019e6e7	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ELESTRIN	ESTRADIOL	Viatris Specialty LLC	eff2dea1-f117-11e3-ac10-0800200c9a66	2023-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	31646359-292c-4bca-88a4-7a89b11c3f44	2023-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Vivelle-Dot	ESTRADIOL	Sandoz Inc	5ccb77f9-d47b-4381-ad5c-5b92524e1c4a	2023-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estrogen 4X	ESTRADIOL	Nutritional Specialties, Inc.	772c2a8a-10e2-49af-8db6-4d5ca64b1719	2023-07-25	Warnings	Name fallback generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Lifesciences Limited	2f2030c2-f72e-4142-9cff-540bc8fbf8a1	2023-04-21		Name fallback brand name: estradiol generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Lifesciences Limited	8b672c79-0896-4d6e-b225-299e89068ad7	2023-04-21		Name fallback brand name: estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Lifesciences Limited	b79fd5ea-962f-491c-b670-40efe42ccf79	2022-12-07		Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	229b4ec5-d3c8-4406-9fc5-8f633c6447b8	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	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