Application 208564

Type: NDA
Sponsor: THERAPEUTICSMD INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMVEXXY	ESTRADIOL	INSERT;VAGINAL	0.004MG	Yes	No
002	IMVEXXY	ESTRADIOL	INSERT;VAGINAL	0.01MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208564-001	IMVEXXY	ESTRADIOL	0.004MG	INSERT / VAGINAL	AB	RLD, RS	2018-05-29
N208564-002	IMVEXXY	ESTRADIOL	0.01MG	INSERT / VAGINAL	AB	RLD, RS	2018-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N208564-001	AB
N208564-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 66 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208564-001	10258630	2032-11-21	U-2316		2019-04-18
N208564-001	10258630	2032-11-21	U-2317		2019-04-18
N208564-001	10398708	2032-11-21	U-2317		2019-09-12
N208564-001	10398708	2032-11-21	U-2614		2019-09-12
N208564-001	10471072	2032-11-21	U-2316		2019-12-06
N208564-001	10471072	2032-11-21	U-2317		2019-12-06
N208564-001	10537581	2032-11-21	U-2316	Drug product	2020-02-13
N208564-001	10537581	2032-11-21	U-2317	Drug product	2020-02-13
N208564-001	10568891	2032-11-21	U-2316		2020-03-19
N208564-001	10568891	2032-11-21	U-2317		2020-03-19
N208564-001	10668082	2032-11-21	U-2316		2020-06-10
N208564-001	10668082	2032-11-21	U-2317		2020-06-10
N208564-001	10806697	2032-11-21		Drug product	2020-10-22
N208564-001	10835487	2032-11-21	U-2316		2020-11-18
N208564-001	10835487	2032-11-21	U-2317		2020-11-18
N208564-001	10888516	2032-11-21	U-2316		2021-02-08
N208564-001	10888516	2032-11-21	U-2317		2021-02-08
N208564-001	11065197	2032-11-21		Drug product	2021-08-05
N208564-001	11116717	2032-11-21		Drug product	2021-09-24
N208564-001	11123283	2032-11-21		Drug product	2021-09-24
N208564-001	11241445	2032-11-21	U-2316		2022-02-18
N208564-001	11241445	2032-11-21	U-2317		2022-02-18
N208564-001	11246875	2032-11-21	U-2316		2022-02-18
N208564-001	11246875	2032-11-21	U-2317		2022-02-18
N208564-001	11304959	2032-11-21		Drug product	2022-04-20
N208564-001	11351182	2032-11-21	U-2316		2022-06-09
N208564-001	11351182	2032-11-21	U-2317		2022-06-09
N208564-001	9180091	2032-11-21	U-2316	Drug product	2018-06-19
N208564-001	9180091	2032-11-21	U-2317	Drug product	2018-06-19
N208564-001	9289382	2032-11-21		Drug product	2018-06-19
N208564-001	11266661	2034-02-02	U-2316		2022-03-11
N208564-001	11266661	2034-02-02	U-2317		2022-03-11
N208564-002	10258630	2032-11-21	U-2316		2019-04-18
N208564-002	10258630	2032-11-21	U-2317		2019-04-18
N208564-002	10398708	2032-11-21	U-2317		2019-09-12
N208564-002	10398708	2032-11-21	U-2614		2019-09-12
N208564-002	10471072	2032-11-21	U-2316		2019-12-06
N208564-002	10471072	2032-11-21	U-2317		2019-12-06
N208564-002	10537581	2032-11-21	U-2316	Drug product	2020-02-13
N208564-002	10537581	2032-11-21	U-2317	Drug product	2020-02-13
N208564-002	10568891	2032-11-21	U-2316		2020-03-19
N208564-002	10568891	2032-11-21	U-2317		2020-03-19
N208564-002	10668082	2032-11-21	U-2316		2020-06-10
N208564-002	10668082	2032-11-21	U-2317		2020-06-10
N208564-002	10806697	2032-11-21		Drug product	2020-10-22
N208564-002	10835487	2032-11-21	U-2316		2020-11-18
N208564-002	10835487	2032-11-21	U-2317		2020-11-18
N208564-002	10888516	2032-11-21	U-2316		2021-02-08
N208564-002	10888516	2032-11-21	U-2317		2021-02-08
N208564-002	11065197	2032-11-21		Drug product	2021-08-05
N208564-002	11116717	2032-11-21		Drug product	2021-09-24
N208564-002	11123283	2032-11-21		Drug product	2021-09-24
N208564-002	11241445	2032-11-21	U-2316		2022-02-18
N208564-002	11241445	2032-11-21	U-2317		2022-02-18
N208564-002	11246875	2032-11-21	U-2316		2022-02-18
N208564-002	11246875	2032-11-21	U-2317		2022-02-18
N208564-002	11304959	2032-11-21		Drug product	2022-04-20
N208564-002	11351182	2032-11-21	U-2316		2022-06-09
N208564-002	11351182	2032-11-21	U-2317		2022-06-09
N208564-002	11497709	2032-11-21	U-2316		2022-11-21
N208564-002	11497709	2032-11-21	U-2317		2022-11-21
N208564-002	9180091	2032-11-21	U-2316	Drug product	2018-06-19
N208564-002	9180091	2032-11-21	U-2317	Drug product	2018-06-19
N208564-002	9289382	2032-11-21		Drug product	2018-06-19
N208564-002	11266661	2034-02-02	U-2316		2022-03-11
N208564-002	11266661	2034-02-02	U-2317		2022-03-11

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 3 · 82 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	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL	AB	RLD, RS	2018-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL	AB	RLD, RS	2018-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL	AB	RLD	2018-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL	AB	RLD, RS	2018-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208564-001	IMVEXXY	0.004MG	INSERT / VAGINAL		RLD	2018-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208564-002	IMVEXXY	0.01MG	INSERT / VAGINAL		RLD, RS	2018-05-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208564-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208564-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208564-002	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208564-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208564-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 59 · 2,344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208564-001	10258630	2032-11-21	U-2316		2019-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10258630	2032-11-21	U-2317		2019-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10398708	2032-11-21	U-2317		2019-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10398708	2032-11-21	U-2614		2019-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10471072	2032-11-21	U-2317		2019-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10471072	2032-11-21	U-2316		2019-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10537581	2032-11-21	U-2316	Drug product	2020-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10537581	2032-11-21	U-2317	Drug product	2020-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10568891	2032-11-21	U-2316		2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10568891	2032-11-21	U-2317		2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10668082	2032-11-21	U-2317		2020-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10668082	2032-11-21	U-2316		2020-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10806697	2032-11-21		Drug product	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10835487	2032-11-21	U-2316		2020-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10835487	2032-11-21	U-2317		2020-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10888516	2032-11-21	U-2316		2021-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	10888516	2032-11-21	U-2317		2021-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11065197	2032-11-21		Drug product	2021-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11116717	2032-11-21		Drug product	2021-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11123283	2032-11-21		Drug product	2021-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11241445	2032-11-21	U-2316		2022-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11241445	2032-11-21	U-2317		2022-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11246875	2032-11-21	U-2316		2022-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11246875	2032-11-21	U-2317		2022-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11304959	2032-11-21		Drug product	2022-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11351182	2032-11-21	U-2316		2022-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11351182	2032-11-21	U-2317		2022-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	9180091	2032-11-21	U-2317	Drug product	2018-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	9180091	2032-11-21	U-2316	Drug product	2018-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	9289382	2032-11-21		Drug product	2018-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11266661	2034-02-02	U-2316		2022-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-001	11266661	2034-02-02	U-2317		2022-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	10258630	2032-11-21	U-2316		2019-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	10258630	2032-11-21	U-2317		2019-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	10398708	2032-11-21	U-2317		2019-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	10398708	2032-11-21	U-2614		2019-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	10471072	2032-11-21	U-2317		2019-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	10471072	2032-11-21	U-2316		2019-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	10537581	2032-11-21	U-2317	Drug product	2020-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208564-002	10537581	2032-11-21	U-2316	Drug product	2020-02-13	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208564-001	NP	2021-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208564-002	NP	2021-05-29	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208564-001	NP	2021-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208564-002	NP	2021-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208564-001	NP	2021-05-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208564-002	NP	2021-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208564-001	NP	2021-05-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208564-002	NP	2021-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208564-001	NP	2021-05-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208564-002	NP	2021-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208564-001	NP	2021-05-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208564-002	NP	2021-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208564-001	NP	2021-05-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208564-002	NP	2021-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208564-001	NP	2021-05-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208564-002	NP	2021-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208564-001	NP	2021-05-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208564-002	NP	2021-05-29	`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 · 134 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Alvogen Inc.	0178a92c-62b1-d5cf-cf54-2c85af88a74a	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	NorthStar Rx LLC	1c2cd11a-e010-20b2-e063-6294a90a52d5	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	ff28c624-906d-459c-8b8c-27cb1a664e12	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 generic name: ESTRADIOL
Estradiol	ESTRADIOL	A-S Medication Solutions	13f9c41b-417c-45e4-9a59-baf774fca78d	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback 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 generic name: ESTRADIOL
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	f4efb0bf-b96f-4e20-a0f2-0806ab92b2d4	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Coupler LLC	37c99e4d-fb0d-0e6e-e063-6394a90a69c8	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	d28bec8f-762e-4f05-a20d-96a42970d6a7	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	NorthStar Rx LLC	0c8a07a4-5762-eaf4-e063-6394a90a54ff	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	American Health Packaging	265a1ee1-f314-4324-a2e1-0120a9a00a20	2025-05-02	Boxed warning, 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
50261-104	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-104	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-104	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-104	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-104	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-104	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-104	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-110	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-110	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-110	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-110	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-110	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-110	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current
50261-110	IMVEXXY	estradiol	TherapeuticsMD, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77575	SUPPL	2024-02-20
77554	SUPPL	2024-02-16
69340	SUPPL	2021-11-17
69335	SUPPL	2021-11-17
61033	SUPPL	2019-11-22
61021	SUPPL	2019-11-22
57394	ORIG	2019-02-01
54411	ORIG	2018-06-01
54392	ORIG	2018-05-31