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 7 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	db4696da-7820-4b2b-97b4-fb05b1208020	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	839fe7ae-6835-4d6a-b6b1-ca7f062caa4f	2024-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Sandoz Inc	c4da6de7-9ab1-4fcf-88f3-fe785019e6e7	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Minivelle	ESTRADIOL	Noven Therapeutics, LLC	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	2024-02-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 generic name: ESTRADIOL
estradiol	ESTRADIOL	Zydus Lifesciences Limited	8b672c79-0896-4d6e-b225-299e89068ad7	2023-04-21		Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	Zydus Lifesciences Limited	b79fd5ea-962f-491c-b670-40efe42ccf79	2022-12-07		Name fallback generic name: ESTRADIOL
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	229b4ec5-d3c8-4406-9fc5-8f633c6447b8	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	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