Application 076901
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | No | No |
| 002 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | No | No |
| 003 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076901-001 | MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | ||
| A076901-002 | MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | ||
| A076901-003 | MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 |
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 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076901-002 | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076901-003 | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076901-001 | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-28 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076901-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076901-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076901-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A076901-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076901-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076901-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076901-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076901-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076901-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076901-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076901-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076901-003 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Mirtazapine | MIRTAZAPINE | Prasco Laboratories | 8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4 | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Mylan Pharmaceuticals Inc. | 711aa80b-8fc6-49e6-9494-3db31d9b53a4 | 2022-10-04 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | 3b516a33-b164-4e4f-bc18-e9d1e591323a | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | 0f19ab40-1a30-4ac2-9bd7-c2f8199e29e1 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | a2f01ffd-fd48-499b-9126-8eb9048a5722 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Sun Pharmaceutical Industries, Inc. | f23631be-c7ae-46e9-b771-a70be17bc9f0 | 2021-11-30 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 500dbfbe-2a00-496d-9e44-6e59d2c68ea2 | 2021-08-20 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | a96e0d95-1a7b-4588-923a-2169b5506203 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 93c4ddcf-ca4f-4a46-a7b7-1395fb0885d2 | 2020-11-11 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | NCS HealthCare of KY, Inc dba Vangard Labs | 20a724c6-feba-40e7-a35a-8a37de2e0136 | 2019-03-08 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 3bda4994-cdf5-47b4-aebc-7297347334e9 | 2018-08-24 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 6ad0e695-92ee-4900-b194-a2455473370b | 2018-07-31 | Boxed warning, Warnings, Adverse reactions | Mirtazapine MIRTAZAPINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44325 | ORIG | 2005-08-01 |