Application 203723

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRADIOL VALERATE	ESTRADIOL VALERATE	INJECTABLE;INJECTION	10MG/ML	No	No
002	ESTRADIOL VALERATE	ESTRADIOL VALERATE	INJECTABLE;INJECTION	20MG/ML	No	No
003	ESTRADIOL VALERATE	ESTRADIOL VALERATE	INJECTABLE;INJECTION	40MG/ML	No	No

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	Approval date
A203723-001	ESTRADIOL VALERATE	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21
A203723-002	ESTRADIOL VALERATE	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21
A203723-003	ESTRADIOL VALERATE	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203723-001	AO
A203723-002	AO
A203723-003	AO

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 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203723-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203723-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203723-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	2020-04-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A203723-001	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203723-002	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203723-003	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203723-001	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203723-002	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203723-003	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203723-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203723-002	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203723-003	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203723-001	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203723-002	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203723-003	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203723-001	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203723-002	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203723-003	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203723-001	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203723-002	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203723-003	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203723-001	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203723-002	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203723-003	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203723-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203723-002	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203723-003	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203723-001	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203723-002	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203723-003	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203723-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203723-002	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203723-003	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203723-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203723-002	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203723-003	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203723-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203723-002	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203723-003	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203723-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203723-002	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203723-003	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203723-001	AO	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol Valerate	ESTRADIOL VALERATE	Hikma Pharmaceuticals USA Inc.	66f40ab0-4432-4e85-b709-a0bc076868c6	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203723 application number: ANDA203723 ndc (product): 0143-9290 ndc (product): 0143-9291 ndc (product): 0143-9289

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9289	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9289	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9289	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9289	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9290	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9290	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9290	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9290	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9291	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9291	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9291	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9291	Estradiol Valerate	Estradiol Valerate	Hikma Pharmaceuticals USA Inc.	ANDA	Current