Application 091165
- Type
- ANDA
- Sponsor
- WOCKHARDT LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESZOPICLONE | ESZOPICLONE | TABLET;ORAL | 1MG | No | No |
| 002 | ESZOPICLONE | ESZOPICLONE | TABLET;ORAL | 2MG | No | No |
| 003 | ESZOPICLONE | ESZOPICLONE | TABLET;ORAL | 3MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091165-001 | ESZOPICLONE | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | ||
| A091165-002 | ESZOPICLONE | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | ||
| A091165-003 | ESZOPICLONE | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 |
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 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091165-002 | ESZOPICLONE | 2MG | TABLET / ORAL | 2011-07-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091165-003 | ESZOPICLONE | 3MG | TABLET / ORAL | 2011-07-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091165-001 | ESZOPICLONE | 1MG | TABLET / ORAL | 2011-07-14 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Eszopiclone | ESZOPICLONE | St Mary's Medical Park Pharmacy | c4ff1d6a-918e-c046-e053-2a95a90a9c9b | 2026-06-20 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | Bryant Ranch Prepack | e04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | Preferred Pharmaceuticals Inc. | 2b5b4fbb-9b86-46c6-9508-37d3d9806dec | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| ESZOPICLONE | ESZOPICLONE | Preferred Pharmaceuticals, Inc. | 45558f0a-83f1-49b9-ab18-f436c0be9677 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | ESZOPICLONE ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | REMEDYREPACK INC. | 61fd4655-060f-4393-a610-019d8b127058 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | Preferred Pharmaceuticals Inc. | abe3a610-a25d-4b52-8537-c87e8ba3104a | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | Preferred Pharmaceuticals Inc. | 0102ea59-77b1-4e74-83ec-1d205563b55f | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | NuCare Pharmaceuticals,Inc. | c24ec179-f869-746f-e053-2995a90aa1ff | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | Asclemed USA, Inc. | 838559f7-4b69-4831-bf50-ab37c6c24c2b | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| ESZOPICLONE | ESZOPICLONE | DIRECT RX | 486b760b-7fea-306b-e054-00144ff8d46c | 2026-03-05 | Warnings, Adverse reactions | ESZOPICLONE ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | dd7e4bab-8e25-4788-89e4-6b391f9596fe | 2026-02-01 | Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | Glenmark Pharmaceuticals Inc. USA | 584dc66c-063a-4552-a056-74b811e2bc80 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | 7df922bc-5750-4259-906f-64f960c38d5f | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | ESZOPICLONE ESZOPICLONE |
| ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | 57a8450c-59ee-4c96-bef4-308fa7b97d1e | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | ESZOPICLONE ESZOPICLONE |
| ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | bfa767ce-340b-4d3a-a9c7-0043b6d7ff6e | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | ESZOPICLONE ESZOPICLONE |
| ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | e261bf7f-1b89-4393-8c48-4e72fc29192f | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | ESZOPICLONE ESZOPICLONE |
| ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | 923cc646-f22a-4a26-88f7-a19fce016321 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | ESZOPICLONE ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | 4832cfbf-a540-46af-bb7d-3ba8e6bc783e | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |
| ESZOPICLONE | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | bb972d36-4b2c-45ae-8504-3a16d352dd8b | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | ESZOPICLONE ESZOPICLONE |
| Eszopiclone | ESZOPICLONE | Bryant Ranch Prepack | f6022b2f-9b43-40cc-91c7-c224b209efab | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | Eszopiclone ESZOPICLONE |