Estradiol

Product NDC: 66267-093
11-digit product format: 662670093
Labeler code: 66267
Product ID: 66267-093_9cae2017-ea8a-2206-e053-2995a90a82ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA040197
Marketing category: ANDA
Marketing start: 1997-10-28
Marketing end: 0000-00-00
Substance: ESTRADIOL
Active strength: 2 mg/1
Pharmacologic classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66267-093		D	Discontinued by firm	2026-08-03
excluded package	package	66267-093	66267-093-30	D	Discontinued by firm	2026-08-03
excluded package	package	66267-093	66267-093-60	D	Discontinued by firm	2026-08-03
excluded package	package	66267-093	66267-093-91	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66267-093-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66267-093-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66267-093-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66267-093-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66267-093-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66267-093-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66267-093-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66267-093-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66267-093-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66267-093-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66267-093-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66267-093-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66267-093-91	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66267-093-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66267-093-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66267-093-91	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66267-093-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66267-093-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66267-093-91	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66267-093-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66267-093-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66267-093-91	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66267-093-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66267-093-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66267-093-91	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66267-093-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66267-093-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66267-093-91	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66267-093-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66267-093-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66267-093-91	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66267-093-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66267-093-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66267-093-91	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66267-093-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66267-093-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	TE codes	RLD / RS	Approval date
A040197-001	ESTRADIOL	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22
A040197-002	ESTRADIOL	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22
A040197-003	ESTRADIOL	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040197-001	AB
A040197-002	AB
A040197-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040197-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040197-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66267-093-60	EA - Each	66267-093	cf5a95f3-cfb0-4d69-b5a6-fac66ccc8a21	1	2016-10-06

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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	REMEDYREPACK INC.	774ee81b-8e29-46af-ab12-7157f63b443b	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Northwind Health Company, LLC	f6caf47a-1917-c493-e053-6394a90af63e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Northwind Health Company, LLC	f6cb38ab-fdff-9c07-e053-6294a90ad59a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	f3a77482-f490-f350-e053-2a95a90ad8cb	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	c8ac2e13-58d5-4e70-e053-2995a90aff04	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	American Health Packaging	265a1ee1-f314-4324-a2e1-0120a9a00a20	2025-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	A-S Medication Solutions	3e84e3e7-4b50-407f-a215-45363b541384	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	d0d1c2c8-b175-4250-9343-d7db65b72e8f	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	dd7d2d2a-e76b-7dfe-e053-2995a90a790a	2025-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PharmPak, Inc.	20b50139-4e13-4f0c-aaf5-ecb83911d9e6	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Proficient Rx LP	7e570b07-2a9e-49bf-b224-1e34f6eda3ab	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	A-S Medication Solutions	7f3c96ce-c855-4372-95ba-7759dd82bcca	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Bryant Ranch Prepack	80d6644a-d6f2-48e7-a685-92c4255b19fe	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Bryant Ranch Prepack	414b846a-d6d9-4e8a-9632-12e296fc13c3	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197