Application 076921
- Type
- ANDA
- Sponsor
- AUROBINDO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 7.5MG | No | No |
| 002 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 15MG | No | No |
| 003 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 30MG | No | No |
| 004 | 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 |
|---|---|---|---|---|---|---|---|
| A076921-001 | MIRTAZAPINE | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | |
| A076921-002 | MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | |
| A076921-003 | MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | |
| A076921-004 | MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076921-001 | AB |
| A076921-002 | AB |
| A076921-003 | AB |
| A076921-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076921-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076921-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076921-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076921-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076921-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076921-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076921-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076921-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-004 | AB | 1 | 5bbf6a4d5a75… |
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 | Proficient Rx LP | 0f19ab40-1a30-4ac2-9bd7-c2f8199e29e1 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | a96e0d95-1a7b-4588-923a-2169b5506203 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | NCS HealthCare of KY, Inc dba Vangard Labs | 20a724c6-feba-40e7-a35a-8a37de2e0136 | 2019-03-08 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 0615-8268 0615-8269 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 3bda4994-cdf5-47b4-aebc-7297347334e9 | 2018-08-24 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 6ad0e695-92ee-4900-b194-a2455473370b | 2018-07-31 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
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 |
|---|---|---|---|---|---|
| 0615-7870 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8268 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8269 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 13107-001 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-001 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-001 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-001 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-001 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-003 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-003 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-003 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-003 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-003 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-031 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-031 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-031 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-031 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-031 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-032 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-032 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-032 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-032 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 13107-032 | Mirtazapine | Mirtazapine | Aurolife Pharma LLC | ANDA | Current |
| 17856-0101 | Mirtazapine | Mirtazapine | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 21695-081 | Mirtazapine | Mirtazapine | Rebel Distributors Corp. | ANDA | Current |
| 21695-082 | Mirtazapine | Mirtazapine | Rebel Distributors Corp. | ANDA | Current |
| 21695-083 | Mirtazapine | Mirtazapine | Rebel Distributors Corp. | ANDA | Current |
| 33261-073 | Mirtazapine | Mirtazapine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 43353-535 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-535 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-536 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-536 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-614 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-137 | Mirtazapine | Mirtazapine | Medsource Pharmaceuticals | ANDA | Current |
| 45865-382 | Mirtazapine | Mirtazapine | Medsource Pharmaceuticals | ANDA | Current |
| 45865-382 | Mirtazapine | Mirtazapine | Medsource Pharmaceuticals | ANDA | Current |
| 49999-629 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-629 | Mirtazapine | Mirtazapine | Quality Care Products LLC | ANDA | Current |
| 49999-629 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-629 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-629 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-629 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-629 | Mirtazapine | Mirtazapine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-1057 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-1057 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-2140 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-2558 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-2558 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-2558 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-2800 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-2800 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-2800 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-2800 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-4123 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 50090-4643 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 52959-902 | Mirtazapine | Mirtazapine | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-1474 | Mirtazapine | Mirtazapine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1474 | Mirtazapine | Mirtazapine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2712 | Mirtazapine | Mirtazapine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0646 | Mirtazapine | Mirtazapine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-7141 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-7141 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 57237-007 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-007 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-007 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-007 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-007 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-007 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-007 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-007 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-008 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-008 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-008 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-008 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-008 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-008 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-008 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-008 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-009 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-009 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44326 | ORIG | 2005-08-01 |