Application 206241
- Type
- ANDA
- Sponsor
- ZYDUS NOVELTECH INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESTRADIOL | ESTRADIOL | SYSTEM;TRANSDERMAL | 0.025MG/24HR | No | No |
| 002 | ESTRADIOL | ESTRADIOL | SYSTEM;TRANSDERMAL | 0.0375MG/24HR | No | No |
| 003 | ESTRADIOL | ESTRADIOL | SYSTEM;TRANSDERMAL | 0.05MG/24HR | No | No |
| 004 | ESTRADIOL | ESTRADIOL | SYSTEM;TRANSDERMAL | 0.075MG/24HR | No | No |
| 005 | ESTRADIOL | ESTRADIOL | SYSTEM;TRANSDERMAL | 0.1MG/24HR | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206241-001 | ESTRADIOL | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | |
| A206241-002 | ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | |
| A206241-003 | ESTRADIOL | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | |
| A206241-004 | ESTRADIOL | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | |
| A206241-005 | ESTRADIOL | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206241-001 | AB1 |
| A206241-002 | AB1 |
| A206241-003 | AB1 |
| A206241-004 | AB1 |
| A206241-005 | AB1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206241-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206241-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206241-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206241-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206241-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A206241-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206241-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206241-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206241-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206241-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2022-12-01 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206241-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206241-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206241-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206241-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206241-005 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A206241-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206241-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206241-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206241-004 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206241-005 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206241-005 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206241-005 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206241-005 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-004 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206241-005 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206241-005 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-004 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206241-005 | AB1 | 1 | 03ed91905a0d… |
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 | Zydus Pharmaceuticals USA Inc. | 839fe7ae-6835-4d6a-b6b1-ca7f062caa4f | 2024-03-15 | Boxed warning, Warnings, Adverse reactions | 206241 ANDA206241 |
| Estradiol | ESTRADIOL | Zydus Lifesciences Limited | b79fd5ea-962f-491c-b670-40efe42ccf79 | 2022-12-07 | 206241 ANDA206241 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.