Home Applications 021633 Application 021633
Type NDA
Sponsor APIL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FEMTRACE ESTRADIOL ACETATE TABLET;ORAL 0.45MG Yes No 002 FEMTRACE ESTRADIOL ACETATE TABLET;ORAL 0.9MG Yes No 003 FEMTRACE ESTRADIOL ACETATE TABLET;ORAL 1.8MG Yes 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 RLD / RS Approval date N021633-001 FEMTRACE ESTRADIOL ACETATE 0.45MG TABLET / ORAL RLD 2004-08-20 N021633-002 FEMTRACE ESTRADIOL ACETATE 0.9MG TABLET / ORAL RLD 2004-08-20 N021633-003 FEMTRACE ESTRADIOL ACETATE 1.8MG TABLET / ORAL RLD 2004-08-20
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 · 123 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 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021633-002 FEMTRACE 0.9MG TABLET / ORAL RLD 2004-08-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021633-003 FEMTRACE 1.8MG TABLET / ORAL RLD 2004-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021633-001 FEMTRACE 0.45MG TABLET / ORAL RLD 2004-08-20 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 5 · 171 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021633-001 7572779 2025-10-02 U-904 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021633-002 7572779 2025-10-02 U-904 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021633-003 7572779 2025-10-02 U-904 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021633-001 7572779 2025-10-02 U-904 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021633-002 7572779 2025-10-02 U-904 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021633-003 7572779 2025-10-02 U-904 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021633-001 7572779 2025-10-02 U-904 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021633-002 7572779 2025-10-02 U-904 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021633-003 7572779 2025-10-02 U-904 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021633-001 7572779 2025-10-02 U-904 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021633-002 7572779 2025-10-02 U-904 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021633-003 7572779 2025-10-02 U-904 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021633-001 7572779 2025-10-02 U-904 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021633-002 7572779 2025-10-02 U-904 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021633-003 7572779 2025-10-02 U-904 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021633-001 7572779 2025-10-02 U-904 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021633-002 7572779 2025-10-02 U-904 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021633-003 7572779 2025-10-02 U-904 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021633-001 7572779 2025-10-02 U-904 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021633-002 7572779 2025-10-02 U-904 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021633-003 7572779 2025-10-02 U-904 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021633-001 7572779 2025-10-02 U-904 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021633-002 7572779 2025-10-02 U-904 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021633-003 7572779 2025-10-02 U-904 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021633-001 7572779 2025-10-02 U-904 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021633-002 7572779 2025-10-02 U-904 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021633-003 7572779 2025-10-02 U-904 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021633-001 7572779 2025-10-02 U-904 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021633-002 7572779 2025-10-02 U-904 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021633-003 7572779 2025-10-02 U-904 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021633-001 7572779 2025-10-02 U-904 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021633-002 7572779 2025-10-02 U-904 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021633-003 7572779 2025-10-02 U-904 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021633-001 7572779 2025-10-02 U-904 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021633-002 7572779 2025-10-02 U-904 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021633-003 7572779 2025-10-02 U-904 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021633-001 7572779 2025-10-02 U-904 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021633-002 7572779 2025-10-02 U-904 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021633-003 7572779 2025-10-02 U-904 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021633-001 7572779 2025-10-02 U-904 5c6f7cd8ea54…
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.
Documents# Document, Submission type, Date table Document Submission type Date 50288 SUPPL 2017-11-03 5894 SUPPL 2014-08-14 15904 SUPPL 2014-08-13 42244 ORIG 2005-12-01 5893 ORIG 2004-08-25