Home Applications 216055 Application 216055
Type ANDA
Sponsor AMNEAL 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 43 .
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 A216055-001 ESTRADIOL ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 A216055-002 ESTRADIOL ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 A216055-003 ESTRADIOL ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 A216055-004 ESTRADIOL ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 A216055-005 ESTRADIOL ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12
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.
Product history page 1 of 2 · 70 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 2026-09-14 22:38:34 2026-08 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-001 ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-002 ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-003 ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-004 ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216055-005 ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB 2024-07-12 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Estradiol ESTRADIOL TRANSDERMAL Amneal Pharmaceuticals NY LLC 9669a0e3-27e2-4f6c-961c-7a67e9f84cc8 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216055 application number: ANDA216055
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.