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 6 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	A-S Medication Solutions	7f3c96ce-c855-4372-95ba-7759dd82bcca	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	NuCare Pharmaceuticals, Inc.	5423c0da-eb10-20cd-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
DOTTI	ESTRADIOL	Bryant Ranch Prepack	99b889a0-6200-4727-97d3-f5a0b7814e1b	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	9eb88585-4994-474f-bd63-c4e003bf6f20	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	7eb1b2c3-8ece-47c3-96c0-606f7f5b5a32	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	d9514497-6b9e-4c13-950b-6b036ff101c1	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	1bbdb10b-9a32-3899-e063-6294a90ab26d	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	NuCare Pharmaceuticals,Inc.	7093dbe4-b096-2ddb-e053-2991aa0a1bb8	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
ESTRACE	ESTRADIOL	Allergan, Inc.	dfc41fcd-c5ba-4b25-b647-cf04d3988b3e	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	d4259bb8-91f8-4587-8ceb-35d44145aec0	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
LYLLANA	ESTRADIOL	Amneal Pharmaceuticals LLC	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	0500ee9b-bf4a-4432-9afe-20a7d60a6fe5	2024-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
DOTTI	ESTRADIOL	Amneal Pharmaceuticals LLC	53016d30-6b5f-49da-ac16-85ef415a5805	2024-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	0e927450-3f02-4d2f-9235-a255357e8d93	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	6a4e82a4-d980-4c04-9e33-9444a292728a	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	eab9a629-b3d4-4faf-bce4-656fe3b46d38	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL generic name: ESTRADIOL
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	3fe899db-a8cd-4a31-88fb-1129be96b4d9	2024-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Noven Therapeutics, LLC	bf185599-2138-4083-9c52-2b95dce09ae0	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	80d6644a-d6f2-48e7-a685-92c4255b19fe	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol generic name: ESTRADIOL
Estradiol	ESTRADIOL	Bryant Ranch Prepack	414b846a-d6d9-4e8a-9632-12e296fc13c3	2024-04-04	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