Application 077666
- Type
- ANDA
- Sponsor
- APOTEX INC
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 |
|---|---|---|---|---|---|---|---|
| A077666-001 | MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | |
| A077666-002 | MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | |
| A077666-003 | MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077666-001 | AB |
| A077666-002 | AB |
| A077666-003 | 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 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 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 | A077666-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077666-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077666-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077666-001 | 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 | A-S Medication Solutions | 44779383-3ddb-41df-8766-da5d7bef385e | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Direct_Rx | dea8c09a-b759-1da7-e053-2a95a90a3346 | 2026-01-08 | Warnings, Adverse reactions | 077666 ANDA077666 61919-153 |
| Mirtazapine | MIRTAZAPINE | Cardinal Health 107, LLC | df06ea51-a962-49d0-a449-137e2220ce7e | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 55154-7297 |
| Mirtazapine | MIRTAZAPINE | Apotex Corp. | 9675333e-3064-c8cb-a4b4-6c74d9a82f17 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 60505-0247 60505-0248 60505-0249 |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 3eed8213-a240-fc4b-e063-6294a90a3b05 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Major Pharmaceuticals | a80463be-f2d2-4074-9bd8-5e52b0832b3a | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 0904-6519 |
| Mirtazapine | MIRTAZAPINE | AvKARE | 35922615-7619-3852-e063-6394a90a2e55 | 2025-05-20 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | McKesson Corporation dba SKY Packaging | 40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 63739-099 63739-098 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | ac976282-fb68-4db0-912a-28f075b0716c | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 43353-378 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | faba9bfd-6725-4917-ab48-24e58b397eb4 | 2023-06-29 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | 3b516a33-b164-4e4f-bc18-e9d1e591323a | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 63187-206 63187-471 |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | a2f01ffd-fd48-499b-9126-8eb9048a5722 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 63187-554 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6519 | Mirtazapine | Mirtazapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6519 | Mirtazapine | Mirtazapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6519 | Mirtazapine | Mirtazapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6519 | Mirtazapine | Mirtazapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6519 | Mirtazapine | Mirtazapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6519 | Mirtazapine | Mirtazapine | Major Pharmaceuticals | ANDA | Current |
| 43353-378 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-361 | Mirtazapine | Mirtazapine | Medsource Pharmaceuitcals | ANDA | Current |
| 50090-4222 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 53002-1712 | Mirtazapine | Mirtazapine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1712 | Mirtazapine | Mirtazapine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0482 | Mirtazapine | Mirtazapine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0483 | Mirtazapine | Mirtazapine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0484 | Mirtazapine | Mirtazapine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-7297 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-7297 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-7297 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-7297 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-7297 | Mirtazapine | Mirtazapine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8145 | Mirtazapine | Mirtazapine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8145 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55700-249 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-249 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-249 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-249 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-341 | Mirtazapine | Mirtazapine | Lake Erie Medical Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-341 | Mirtazapine | Mirtazapine | Lake Erie Medical Medical DBA Quality Care Products LLC | ANDA | Current |
| 58118-0052 | Mirtazapine | Mirtazapine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0052 | Mirtazapine | Mirtazapine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0052 | Mirtazapine | Mirtazapine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60505-0247 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0247 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0247 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0247 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0247 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0247 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0247 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0248 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0248 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0248 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0248 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0248 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0248 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0248 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0249 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0249 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0249 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0249 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0249 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0249 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 60505-0249 | Mirtazapine | Mirtazapine | Apotex Corp. | ANDA | Current |
| 61786-208 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 61919-153 | MIRTAZAPINE | MIRTAZAPINE | DirectRX | ANDA | Current |
| 61919-153 | Mirtazapine | Mirtazapine | Direct_Rx | ANDA | Current |
| 61919-154 | MIRTAZAPINE | MIRTAZAPINE | DIRECT RX | ANDA | Current |
| 61919-155 | MIRTAZAPINE | MIRTAZAPINE | Direct Rx | ANDA | Current |
| 63187-206 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63187-206 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63187-206 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63187-471 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63187-471 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63187-471 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63187-554 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63187-554 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63187-554 | Mirtazapine | Mirtazapine | Proficient Rx LP | ANDA | Current |
| 63739-098 | Mirtazapine | Mirtazapine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-098 | Mirtazapine | Mirtazapine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-098 | Mirtazapine | Mirtazapine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-098 | Mirtazapine | Mirtazapine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-099 | Mirtazapine | Mirtazapine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-099 | Mirtazapine | Mirtazapine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-099 | Mirtazapine | Mirtazapine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-099 | Mirtazapine | Mirtazapine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 64725-0247 | Mirtazapine | Mirtazapine | TYA Pharmaceuticals | ANDA | Current |
| 65084-475 | Mirtazapine | Mirtazapine | McKesson Corporation dba RX Pak | ANDA | Current |
| 65084-475 | Mirtazapine | Mirtazapine | McKesson Corporation dba RX Pak | ANDA | Current |
| 65084-476 | Mirtazapine | Mirtazapine | McKesson Corporation dba RX Pak | ANDA | Current |
| 65084-476 | Mirtazapine | Mirtazapine | McKesson Corporation dba RX Pak | ANDA | Current |
| 68071-4003 | Mirtazapine | Mirtazapine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4045 | Mirtazapine | Mirtazapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |