Application 210022
- Type
- ANDA
- Sponsor
- CADILA PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 2.5MG | No | No |
| 002 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 5MG | No | No |
| 003 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 7.5MG | No | No |
| 004 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 10MG | No | No |
| 005 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 15MG | No | No |
| 006 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210022-001 | OLANZAPINE | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2023-02-24 | |
| A210022-002 | OLANZAPINE | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2023-02-24 | |
| A210022-003 | OLANZAPINE | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2023-02-24 | |
| A210022-004 | OLANZAPINE | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2023-02-24 | |
| A210022-005 | OLANZAPINE | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2023-02-24 | |
| A210022-006 | OLANZAPINE | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2023-02-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210022-001 | AB |
| A210022-002 | AB |
| A210022-003 | AB |
| A210022-004 | AB |
| A210022-005 | AB |
| A210022-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A210022-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2023-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210022-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2023-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210022-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2023-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210022-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2023-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210022-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2023-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210022-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2023-02-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2023-02-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2023-02-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2023-02-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2023-02-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2023-02-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2023-02-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2023-02-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2023-02-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2023-02-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2023-02-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2023-02-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2023-02-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2023-02-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2023-02-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2023-02-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2023-02-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2023-02-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2023-02-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2023-02-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2023-02-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2023-02-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2023-02-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2023-02-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2023-02-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2023-02-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2023-02-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2023-02-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2023-02-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-005 | OLANZAPINE | 15MG | TABLET / ORAL | AB | 2023-02-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-006 | OLANZAPINE | 20MG | TABLET / ORAL | AB | 2023-02-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210022-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | 2023-02-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210022-002 | OLANZAPINE | 5MG | TABLET / ORAL | AB | 2023-02-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210022-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | 2023-02-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210022-004 | OLANZAPINE | 10MG | TABLET / ORAL | AB | 2023-02-24 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A210022-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210022-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210022-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210022-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210022-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210022-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210022-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210022-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210022-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210022-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210022-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210022-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210022-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210022-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210022-004 | AB | 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 |
|---|---|---|---|---|---|---|
| Olanzapine | OLANZAPINE | Modavar Pharmaceuticals LLC | f0943b4e-6bdc-48c1-8ecd-39cf732e16f5 | 2026-04-06 | Boxed warning, Warnings, Adverse reactions | 210022 ANDA210022 |
| Olanzapine | OLANZAPINE | Coupler LLC | 495efc49-7cdb-4b9e-e063-6394a90a547e | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | 210022 ANDA210022 |
| Olanzapine | OLANZAPINE | Coupler LLC | 42d9ad47-52cc-ad11-e063-6394a90aedca | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 210022 ANDA210022 |
| Olanzapine | OLANZAPINE | Coupler LLC | 40187874-447a-de20-e063-6394a90aafe7 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 210022 ANDA210022 |
| Olanzapine | OLANZAPINE | Coupler LLC | 3ed78a7d-4014-d280-e063-6294a90a8ee9 | 2025-09-15 | Boxed warning, Warnings, Adverse reactions | 210022 ANDA210022 |
| Olanzapine | OLANZAPINE | Cadila Pharmaceuticals Limited | 2ae07ad4-4e58-4740-9f02-035ec061fefc | 2025-03-11 | Boxed warning, Warnings, Adverse reactions | 210022 ANDA210022 |