Application 040628

Type: ANDA
Sponsor: FOSUN PHARMA

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 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
A040628-001	ESTRADIOL VALERATE	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04
A040628-002	ESTRADIOL VALERATE	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04
A040628-003	ESTRADIOL VALERATE	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04

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	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040628-002	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	2007-10-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040628-003	ESTRADIOL VALERATE	40MG/ML	INJECTABLE / INJECTION	2007-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040628-001	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	2007-10-04	`301d65b070ca…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol valerate	ESTRADIOL VALERATE	Xiromed, LLC	2e5c7559-7420-168d-6272-92bb4d20035d	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol valerate generic name: ESTRADIOL VALERATE
Delestrogen	ESTRADIOL VALERATE	Par Health USA, LLC	e8f94df9-0692-4462-a7f0-fe019a0a3f07	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESTRADIOL VALERATE
Estradiol Valerate	ESTRADIOL VALERATE	Hikma Pharmaceuticals USA Inc.	66f40ab0-4432-4e85-b709-a0bc076868c6	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Estradiol Valerate generic name: ESTRADIOL VALERATE
ESTRADIOL VALERATE	ESTRADIOL VALERATE	American Regent, Inc.	2984bce2-89bf-4768-a1ca-ccf03b1197be	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESTRADIOL VALERATE generic name: ESTRADIOL VALERATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.