Application 076541
- Type
- ANDA
- Sponsor
- SUN PHARM INDS 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 |
| 004 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 7.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076541-001 | MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | |
| A076541-002 | MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | |
| A076541-003 | MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | |
| A076541-004 | MIRTAZAPINE | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076541-001 | AB |
| A076541-002 | AB |
| A076541-003 | AB |
| A076541-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076541-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076541-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076541-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076541-004 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | RS | 2004-04-22 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076541-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076541-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076541-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076541-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076541-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076541-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076541-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076541-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076541-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076541-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076541-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076541-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076541-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076541-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076541-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076541-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076541-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076541-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076541-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076541-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076541-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076541-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076541-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076541-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076541-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076541-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076541-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076541-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076541-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076541-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076541-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076541-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076541-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076541-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076541-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076541-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076541-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076541-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076541-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076541-004 | AB | 1 | d8e5a09893c0… |
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 | Bryant Ranch Prepack | 577c3ceb-316b-4c93-9b0c-0a4b1b4773e9 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 71335-0441 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | e708e8bb-9b13-44d9-96f5-fd73a893a987 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 356eb045-6347-49cc-818e-65b1cdff8f4e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 |
| Mirtazapine | MIRTAZAPINE | AvKARE | e5478a6a-a29a-9f61-e053-2995a90a11d0 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 42291-494 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 3bb242b0-42ed-471a-b3c4-5ded1e292e80 | 2024-11-27 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 63629-2368 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 8c03eb2b-6aed-40a1-a424-67ac1ab6085d | 2024-09-12 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 63629-2366 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | ecf7826c-c583-4836-9b00-bf9e4b51a144 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 63629-2367 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | ded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5 | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e | 2023-10-26 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 71335-0286 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 1ba111d1-cf92-4cd9-afcb-3bebd1bacd46 | 2023-08-28 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 50ccc34a-4b89-4b07-b153-6c71c6924db1 | 2023-06-06 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 |
| Mirtazapine | MIRTAZAPINE | Sun Pharmaceutical Industries, Inc. | f23631be-c7ae-46e9-b771-a70be17bc9f0 | 2021-11-30 | Boxed warning, Warnings, Adverse reactions | 076541 ANDA076541 57664-499 57664-501 57664-500 57664-510 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8078 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8078 | Mirtazapine | Mirtazapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 16714-706 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-706 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-706 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-707 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-707 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-707 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-708 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-708 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-708 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-709 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-709 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 16714-709 | Mirtazapine | Mirtazapine | Northstar Rx LLC | ANDA | Current |
| 42291-494 | Mirtazapine | Mirtazapine | AvKARE | ANDA | Current |
| 50090-5296 | Mirtazapine | Mirtazapine | A-S Medication Solutions | ANDA | Current |
| 53808-0735 | Mirtazapine | MIRTAZAPINE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0736 | Mirtazapine | MIRTAZAPINE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0737 | Mirtazapine | MIRTAZAPINE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-499 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-500 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-501 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-510 | Mirtazapine | Mirtazapine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-2366 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2366 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2366 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2367 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2367 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2367 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2368 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2368 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2368 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 68071-1659 | Mirtazapine | Mirtazapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1716 | Mirtazapine | Mirtazapine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-1583 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1583 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2582 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2582 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2582 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 71335-0286 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0286 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0286 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0441 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0441 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0441 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0532 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0532 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23831 | ORIG | 2005-08-01 |