Application 214729
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ETYQA | ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL | 0.5MG;0.1MG | No | No |
| 002 | ETYQA | ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL | 1MG;0.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214729-001 | ETYQA | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | 2023-06-30 | ||
| A214729-002 | ETYQA | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | 2023-06-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214729-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2023-06-30 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214729-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2023-06-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214729-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2023-06-30 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214729-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2023-06-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214729-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2023-06-30 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214729-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2023-06-30 | a67488948f0b… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214729-001 | ETYQA | 0.5MG;0.1MG | TABLET / ORAL | 2023-06-30 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214729-002 | ETYQA | 1MG;0.5MG | TABLET / ORAL | 2023-06-30 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-12-20 04:57 UTC | 2023-12 | A214729-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A214729-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214729-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214729-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214729-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214729-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214729-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214729-002 | AB | 1 | a67488948f0b… |
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 |
|---|---|---|---|---|---|---|
| Etyqa | ESTRADIOL AND NORETHINDRONE ACETATE | Aurobindo Pharma Limited | afbc2a33-5eb2-4f01-91e9-07d8050da6ce | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | 214729 ANDA214729 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.