Home Applications 090920 Application 090920
Type ANDA
Sponsor AM REGENT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESTRADIOL VALERATE ESTRADIOL VALERATE INJECTABLE;INJECTION 20MG/ML No No 002 ESTRADIOL VALERATE ESTRADIOL VALERATE INJECTABLE;INJECTION 40MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090920-001 ESTRADIOL VALERATE ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 A090920-002 ESTRADIOL VALERATE ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 2026-08-18 06:07:40 2026-07 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090920-001 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2010-01-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090920-002 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2010-01-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0517-0420 ESTRADIOL VALERATE ESTRADIOL VALERATE American Regent, Inc. ANDA Current 0517-0420 ESTRADIOL VALERATE ESTRADIOL VALERATE American Regent, Inc. ANDA Current 0517-0440 ESTRADIOL VALERATE ESTRADIOL VALERATE American Regent, Inc. ANDA Current 0517-0440 ESTRADIOL VALERATE ESTRADIOL VALERATE American Regent, Inc. ANDA Current 0574-0870 ESTRADIOL VALERATE ESTRADIOL VALERATE Perrigo Company ANDA Current 0574-0870 ESTRADIOL VALERATE ESTRADIOL VALERATE Perrigo Company ANDA Current 0574-0870 ESTRADIOL VALERATE ESTRADIOL VALERATE Perrigo Company ANDA Current 0574-0872 ESTRADIOL VALERATE ESTRADIOL VALERATE Perrigo Company ANDA Current 0574-0872 ESTRADIOL VALERATE ESTRADIOL VALERATE Perrigo Company ANDA Current 0574-0872 ESTRADIOL VALERATE ESTRADIOL VALERATE Perrigo Company ANDA Current