Application 216524
- Type
- ANDA
- Sponsor
- PADAGIS ISRAEL
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216524-001 | ESTRADIOL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | |
| A216524-002 | ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | |
| A216524-003 | ESTRADIOL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | |
| A216524-004 | ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | |
| A216524-005 | ESTRADIOL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216524-001 | AB |
| A216524-002 | AB |
| A216524-003 | AB |
| A216524-004 | AB |
| A216524-005 | AB |
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 | 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 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216524-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-005 | AB | 1 | 5bbf6a4d5a75… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | e6bf2abc-71ae-4e79-a37b-164c98ba746a | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |
| ESTRADIOL | ESTRADIOL | Padagis Israel Pharmaceuticals Ltd | 3ac905b3-904c-4285-97ed-e787d006c7dd | 2026-02-28 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | 0e927450-3f02-4d2f-9235-a255357e8d93 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | 6a4e82a4-d980-4c04-9e33-9444a292728a | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | eab9a629-b3d4-4faf-bce4-656fe3b46d38 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |