Home Applications 214640 Application 214640
Type ANDA
Sponsor XIROMED Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.02MG;0.1MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214640-001 AB3
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.
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 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214640-001 LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;0.1MG TABLET / ORAL AB3 2023-08-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 Joyeaux LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Xiromed, LLC 655b2c93-cfae-d44f-c128-c816bbd88e45 2024-10-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214640 application number: ANDA214640
Documents# Document, Submission type, Date table Document Submission type Date 75394 ORIG 2023-09-12