Application 090881
- Type
- ANDA
- Sponsor
- SUN PHARM INDS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLANZAPINE | OLANZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | No | No |
| 002 | OLANZAPINE | OLANZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | No | No |
| 003 | OLANZAPINE | OLANZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | No | No |
| 004 | OLANZAPINE | OLANZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090881-001 | OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | ||
| A090881-002 | OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | ||
| A090881-003 | OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | ||
| A090881-004 | OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 |
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 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090881-001 | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090881-002 | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090881-003 | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090881-004 | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-02-28 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A090881-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090881-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090881-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090881-004 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090881-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090881-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090881-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090881-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090881-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090881-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090881-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090881-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090881-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090881-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090881-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090881-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090881-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090881-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090881-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090881-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090881-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090881-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090881-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090881-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090881-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090881-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090881-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090881-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090881-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090881-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090881-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090881-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090881-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090881-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090881-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090881-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090881-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090881-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090881-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090881-004 | AB | 1 | 8869cabd3fbd… |
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 | HEC Pharm USA Inc. | 4d1b83db-54db-d51f-e063-6394a90a4a69 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| OLANZAPINE | OLANZAPINE | HEC Pharm USA Inc. | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE OLANZAPINE |
| Olanzapine | OLANZAPINE | Dr.Reddy's Laboratories Limited | aff02cff-d079-bc82-6182-a24c4c6e09a6 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Dr. Reddy's Laboratories Inc. | d474d5a9-d338-511d-5823-567c0a1bbf4d | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| OLANZAPINE | OLANZAPINE | Anthea Pharma Private Limited | e6ffcc56-63f9-4b12-a07a-c6177ffef5e8 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE OLANZAPINE |
| Olanzapine | OLANZAPINE | Macleods Pharmaceuticals Limited | 8e095987-bdea-42f2-9550-c7155cf07d30 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Macleods Pharmaceuticals Limited | df43938a-3469-40eb-8166-f0a2fd29d6d8 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | 2cb1bebe-0ced-46d8-bf21-c28a9acc4a15 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE OLANZAPINE |
| Olanzapine | OLANZAPINE | American Regent, Inc. | e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Teva Pharmaceuticals USA, Inc. | dd0b2525-4e2f-44fc-9302-0ae4ebb1e135 | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Sandoz Inc | c44a96cc-817d-4eb5-a13a-00977f76e666 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | American Health Packaging | c0d705bf-b719-4c7b-b83d-c17d41cbbfad | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Sandoz Inc | 1e9666ef-4271-4834-8496-ccb3125d83db | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| OLANZAPINE | OLANZAPINE | Eugia US LLC | 9c745e2e-89d3-44d4-906e-704705c33310 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE OLANZAPINE |
| Zyprexa | OLANZAPINE | H2-Pharma LLC | b418946a-1ab4-4d89-a012-d94fc361a3c4 | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Aurobindo Pharma Limited | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 495efc49-7cdb-4b9e-e063-6394a90a547e | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Ascend Laboratories, LLC | e8626e68-088d-47ff-bf06-489a778815aa | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Apotex Corp. | 3347d1c8-04c9-5ce1-8cda-b38e0412b709 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 42d9ad47-52cc-ad11-e063-6394a90aedca | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64725-0751 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |
| 64725-0757 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |