Home Applications 218507 Application 218507
Type ANDA
Sponsor ENCUBE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.25GM/PACKET) No No 002 ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.5GM/PACKET) No No 003 ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (0.75GM/PACKET) No No 004 ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1GM/PACKET) No No 005 ESTRADIOL ESTRADIOL GEL;TRANSDERMAL 0.1% (1.25GM/PACKET) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218507-001 ESTRADIOL ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 A218507-002 ESTRADIOL ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 A218507-003 ESTRADIOL ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 A218507-004 ESTRADIOL ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 A218507-005 ESTRADIOL ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218507-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2025-03-05 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.