Application 076122
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 15MG | No | No |
| 002 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 30MG | No | No |
| 003 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 45MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076122-001 | MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | |
| A076122-002 | MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | |
| A076122-003 | MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076122-001 | AB |
| A076122-002 | AB |
| A076122-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076122-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2003-06-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076122-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2003-06-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076122-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2003-06-19 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076122-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076122-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076122-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076122-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076122-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076122-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076122-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076122-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076122-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076122-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076122-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076122-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076122-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076122-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076122-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076122-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076122-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076122-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076122-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076122-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076122-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076122-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076122-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076122-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076122-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076122-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076122-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076122-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076122-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076122-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076122-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076122-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076122-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076122-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076122-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076122-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076122-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076122-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076122-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076122-001 | AB | 1 | 8072bd15b7f6… |
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 | Cardinal Health 107, LLC | 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 |
| Mirtazapine | MIRTAZAPINE | Safecor Health LLC | 6d2ff278-0c80-4373-b77d-b5f186c4b991 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | 412abf0e-1f96-4d4d-bb56-a23d4699b14c | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 |
| Mirtazapine | MIRTAZAPINE | Mylan Institutional Inc. | 6837b69b-2f86-42cf-b48d-b4a3c7b5413f | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 51079-086 51079-087 51079-088 |
| Mirtazapine | MIRTAZAPINE | Cardinal Health 107, LLC | 89ae6a33-933f-47aa-a2de-2a71cd3f7d44 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 55154-5355 |
| Mirtazapine | MIRTAZAPINE | Golden State Medical Supply, Inc. | a6a5949f-5ebf-f37d-e053-2995a90adae5 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 51407-350 51407-351 51407-352 |
| Mirtazapine | MIRTAZAPINE | Mylan Pharmaceuticals Inc. | 711aa80b-8fc6-49e6-9494-3db31d9b53a4 | 2022-10-04 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 0378-3515 0378-3545 0378-3530 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 500dbfbe-2a00-496d-9e44-6e59d2c68ea2 | 2021-08-20 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 71610-523 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 93c4ddcf-ca4f-4a46-a7b7-1395fb0885d2 | 2020-11-11 | Boxed warning, Warnings, Adverse reactions | 076122 ANDA076122 71610-475 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3515 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3530 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3545 | Mirtazapine | Mirtazapine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-5527 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5572 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5572 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5573 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5573 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 43353-962 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-962 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-963 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-963 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51079-086 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-086 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-086 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-087 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-087 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-087 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-088 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-088 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51079-088 | Mirtazapine | Mirtazapine | Mylan Institutional Inc. | ANDA | Current |
| 51407-350 | Mirtazapine | Mirtazapine | Golden State Medical Supply | ANDA | Current |
| 51407-350 | Mirtazapine | Mirtazapine | Golden State Medical Supply | ANDA | Current |
| 51407-350 | Mirtazapine | Mirtazapine | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-350 | Mirtazapine | Mirtazapine | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-351 | Mirtazapine | Mirtazapine | Golden State Medical Supply | ANDA | Current |
| 51407-351 | Mirtazapine | Mirtazapine | Golden State Medical Supply | ANDA | Current |
| 51407-351 | Mirtazapine | Mirtazapine | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-351 | Mirtazapine | Mirtazapine | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-352 | Mirtazapine | Mirtazapine | Golden State Medical Supply | ANDA | Current |
| 51407-352 | Mirtazapine | Mirtazapine | Golden State Medical Supply | ANDA | Current |
| 51407-352 | Mirtazapine | Mirtazapine | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-352 | Mirtazapine | Mirtazapine | Golden State Medical Supply, Inc. | ANDA | Current |
| 53808-0384 | Mirtazapine | Mirtazapine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-5355 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-5355 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-5355 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-5355 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 67046-481 | Mirtazapine | Mirtazapine | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-482 | Mirtazapine | Mirtazapine | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-483 | Mirtazapine | Mirtazapine | Contract Pharmacy Services-PA | ANDA | Current |
| 70518-0102 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0102 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0102 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 71610-475 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-523 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-523 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-523 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |