Application 091038
- Type
- ANDA
- Sponsor
- SUN PHARM INDS
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 |
|---|---|---|---|---|---|---|---|
| A091038-001 | OLANZAPINE | OLANZAPINE | 2.5MG | TABLET / ORAL | 2012-04-23 | ||
| A091038-002 | OLANZAPINE | OLANZAPINE | 5MG | TABLET / ORAL | 2012-04-23 | ||
| A091038-003 | OLANZAPINE | OLANZAPINE | 7.5MG | TABLET / ORAL | 2012-04-23 | ||
| A091038-004 | OLANZAPINE | OLANZAPINE | 10MG | TABLET / ORAL | 2012-04-23 | ||
| A091038-005 | OLANZAPINE | OLANZAPINE | 15MG | TABLET / ORAL | 2012-04-23 | ||
| A091038-006 | OLANZAPINE | OLANZAPINE | 20MG | TABLET / ORAL | 2012-04-23 |
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 | A091038-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | 2012-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091038-002 | OLANZAPINE | 5MG | TABLET / ORAL | 2012-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091038-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | 2012-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091038-004 | OLANZAPINE | 10MG | TABLET / ORAL | 2012-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091038-005 | OLANZAPINE | 15MG | TABLET / ORAL | 2012-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091038-006 | OLANZAPINE | 20MG | TABLET / ORAL | 2012-04-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091038-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | 2012-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091038-002 | OLANZAPINE | 5MG | TABLET / ORAL | 2012-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091038-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | 2012-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091038-004 | OLANZAPINE | 10MG | TABLET / ORAL | 2012-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091038-005 | OLANZAPINE | 15MG | TABLET / ORAL | 2012-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091038-006 | OLANZAPINE | 20MG | TABLET / ORAL | 2012-04-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091038-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | 2012-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091038-002 | OLANZAPINE | 5MG | TABLET / ORAL | 2012-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091038-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | 2012-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091038-004 | OLANZAPINE | 10MG | TABLET / ORAL | 2012-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091038-005 | OLANZAPINE | 15MG | TABLET / ORAL | 2012-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091038-006 | OLANZAPINE | 20MG | TABLET / ORAL | 2012-04-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091038-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | 2012-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091038-002 | OLANZAPINE | 5MG | TABLET / ORAL | 2012-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091038-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | 2012-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091038-004 | OLANZAPINE | 10MG | TABLET / ORAL | 2012-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091038-005 | OLANZAPINE | 15MG | TABLET / ORAL | 2012-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091038-006 | OLANZAPINE | 20MG | TABLET / ORAL | 2012-04-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091038-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | 2012-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091038-002 | OLANZAPINE | 5MG | TABLET / ORAL | 2012-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091038-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | 2012-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091038-004 | OLANZAPINE | 10MG | TABLET / ORAL | 2012-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091038-005 | OLANZAPINE | 15MG | TABLET / ORAL | 2012-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091038-006 | OLANZAPINE | 20MG | TABLET / ORAL | 2012-04-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091038-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | 2012-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091038-002 | OLANZAPINE | 5MG | TABLET / ORAL | 2012-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091038-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | 2012-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091038-004 | OLANZAPINE | 10MG | TABLET / ORAL | 2012-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091038-005 | OLANZAPINE | 15MG | TABLET / ORAL | 2012-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091038-006 | OLANZAPINE | 20MG | TABLET / ORAL | 2012-04-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091038-001 | OLANZAPINE | 2.5MG | TABLET / ORAL | 2012-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091038-002 | OLANZAPINE | 5MG | TABLET / ORAL | 2012-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091038-003 | OLANZAPINE | 7.5MG | TABLET / ORAL | 2012-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091038-004 | OLANZAPINE | 10MG | TABLET / ORAL | 2012-04-23 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A091038-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091038-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091038-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091038-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091038-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091038-006 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091038-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091038-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091038-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091038-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091038-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091038-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091038-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091038-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091038-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091038-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091038-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091038-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091038-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091038-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091038-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091038-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091038-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091038-006 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091038-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091038-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091038-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091038-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091038-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091038-006 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091038-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091038-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091038-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091038-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091038-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091038-006 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091038-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091038-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091038-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091038-004 | AB | 1 | 782e0a99824c… |
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 | Unit Dose Solutions, Inc. | 55668be2-62ac-3252-e063-6394a90a40f7 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | e830f488-c689-40f6-9351-f9c7454ff1ea | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Redpharm Drug | 54adae9e-6781-6a77-e063-6394a90ab5c8 | 2026-06-20 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 549dc142-adcd-99ed-e063-6294a90a37fa | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 53e6b4e9-de26-16c3-e063-6294a90a7764 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 032e589c-47b1-4eb1-9466-8160297b81e9 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Aurobindo Pharma Limited | 4d768cfe-3b20-4127-95b9-b4151b28afcc | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 52b99337-afa8-a6f9-e063-6294a90a2038 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 52bdaaaf-ab54-99d1-e063-6394a90a521f | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | 4e90e30c-78a1-486f-a13c-f1ff798216be | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 51b508ff-dc55-ff36-e063-6294a90a900f | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 51b64b6d-4676-a637-e063-6394a90a450c | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Coupler LLC | 518a9400-edb8-6403-e063-6294a90a065d | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Golden State Medical Supply, Inc. | a1dfb4e7-4143-4422-b7a7-292e4fd75044 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| OLANZAPINE | OLANZAPINE | GLENMARK PHARMACEUTICALS INC., USA | 2e709eaf-4116-4ee3-8dff-ace36181d115 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE OLANZAPINE |
| Olanzapine | OLANZAPINE | Modavar Pharmaceuticals LLC | f0943b4e-6bdc-48c1-8ecd-39cf732e16f5 | 2026-04-06 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | XGen Pharmaceuticals DJB, Inc. | 3aad0f7b-8d0c-a9bf-e063-6394a90a6ae8 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | Strides Pharma Science Limited | 979c3212-36e8-4287-aace-bef0875188d7 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine | OLANZAPINE | REMEDYREPACK INC. | 76a6ff21-7157-4213-8073-35837a3ac07e | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | Olanzapine OLANZAPINE |
| Olanzapine Intramuscular | OLANZAPINE | UBI Pharma Inc. | 6a279fe1-ed99-4a62-b2c7-831961470fa9 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 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 |
|---|---|---|---|---|---|
| 64725-0552 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |
| 64725-0554 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |
| 64725-0555 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |
| 70518-0026 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |