Home Applications 216656 Application 216656
Type ANDA
Sponsor XIROMED 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 Yes
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 A216656-001 ESTRADIOL VALERATE ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 A216656-002 ESTRADIOL VALERATE ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 A216656-003 ESTRADIOL VALERATE ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 · 66 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 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2023-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2023-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2023-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2023-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
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.