Application 078879
- Type
- ANDA
- Sponsor
- BARR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No |
| 002 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No |
| 003 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No |
| 004 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No |
| 005 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No |
| 006 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078879-001 | TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-002 | TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-003 | TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-004 | TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-005 | TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-006 | TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 |
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 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078879-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078879-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078879-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078879-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078879-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078879-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078879-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078879-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078879-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078879-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078879-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078879-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078879-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078879-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078879-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078879-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078879-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078879-006 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078879-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078879-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078879-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078879-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078879-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078879-006 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078879-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078879-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078879-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078879-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078879-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078879-006 | AB | 1 | bb7c543d1eb4… |
| 2020-11-12 02:37 UTC | 2020-11 | A078879-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078879-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078879-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078879-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078879-005 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078879-006 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078879-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078879-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078879-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078879-004 | AB | 1 | 3f01610625f2… |
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 |
|---|---|---|---|---|---|---|
| Temozolomide | TEMOZOLOMIDE | CivicaScript LLC | 56245d21-4a42-471e-bbdc-80b129336e2f | 2026-08-11 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | OPKO Pharmaceuticals, LLC | 9dff10ec-6a55-47b6-a458-b7c39e32dc55 | 2026-07-27 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | OPKO Pharmaceuticals, LLC | f6d762ea-fff0-43e8-b67d-bef19e883dd8 | 2026-07-27 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | OPKO Pharmaceuticals, LLC | f743f7e0-74cf-47e5-bf21-f2b75d2596dc | 2026-07-27 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | OPKO Pharmaceuticals, LLC | b3f69c67-db30-4266-8075-9b18c71c9fc1 | 2026-07-27 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Bryant Ranch Prepack | 79766855-2533-43b1-b60e-1e9daecadad5 | 2026-06-09 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Bryant Ranch Prepack | 021b97cc-a76f-44b6-b7be-670d2ae83690 | 2026-06-09 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Bryant Ranch Prepack | c0f2077c-48e6-452e-9f88-e1f2c89df0a2 | 2026-06-09 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Bryant Ranch Prepack | 38f17780-8037-44a0-9e84-b7150c9bde12 | 2026-06-09 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Bryant Ranch Prepack | 6eb0bd33-582f-43a6-a607-e72b4390c6d3 | 2026-06-09 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Bryant Ranch Prepack | a147b361-262c-49c6-9b8e-7e454f755721 | 2026-06-09 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| TEMODAR | TEMOZOLOMIDE | Merck Sharp & Dohme LLC | 046a9011-3911-4d3f-a15f-fbb56d5aad56 | 2026-02-20 | Warnings, Adverse reactions | TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Sun Pharmaceutical Industries, Inc. | c1e05c21-a411-4493-80de-ede373632475 | 2025-11-14 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Accord Healthcare Inc. | 2d599ccf-8e63-4ff1-aa52-4809744ea97a | 2025-05-23 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Ascend Laboratories, LLC | 33d67bce-38ae-45fc-a858-d51167b0ecfd | 2025-01-09 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Devatis, Inc. | 6b263fe0-5f06-4889-bf14-4aa185470810 | 2024-11-30 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| TEMOZOLOMIDE | TEMOZOLOMIDE | Camber Pharmaceuticals, Inc. | 78c12889-c837-40c1-8f85-4d048008ad29 | 2024-10-19 | Warnings, Adverse reactions | TEMOZOLOMIDE TEMOZOLOMIDE |
| TEMOZOLOMIDE | TEMOZOLOMIDE | Rising Pharma Holdings, Inc. | 70996a9d-4a4f-4ed1-ab07-130486aa14ab | 2024-07-25 | Warnings, Adverse reactions | TEMOZOLOMIDE TEMOZOLOMIDE |
| Temozolomide | TEMOZOLOMIDE | Amneal Pharmaceuticals LLC | 6c8529ec-8936-4fec-a1a5-2b285c7e4859 | 2024-02-17 | Warnings, Adverse reactions | Temozolomide TEMOZOLOMIDE |
| temozolomide | TEMOZOLOMIDE | Nivagen Pharmaceuticals, Inc. | 27e5a781-e4f2-4489-9def-7971d0b86d9c | 2021-11-28 | Boxed warning, Warnings, Adverse reactions | temozolomide TEMOZOLOMIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7599 | Temozolomide | Temozolomide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7600 | Temozolomide | Temozolomide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7601 | Temozolomide | Temozolomide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7602 | Temozolomide | Temozolomide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7638 | Temozolomide | Temozolomide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7639 | Temozolomide | Temozolomide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 23155-774 | Temozolomide | Temozolomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-775 | Temozolomide | Temozolomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-776 | Temozolomide | Temozolomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-777 | Temozolomide | Temozolomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-778 | Temozolomide | Temozolomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-779 | Temozolomide | Temozolomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43151 | ORIG | 2013-05-15 |