Mirtazapine
- Product NDC
- 70518-2018
- 11-digit product format
- 705182018
- Labeler code
- 70518
- Product ID
- 70518-2018_869b858f-655c-2c87-e053-2a91aa0ad913
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2019-04-13
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 45 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-2018 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 70518-2018 | 70518-2018-0 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-2018-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-2018-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-2018-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-2018-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-2018-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-2018-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-2018-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-2018-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-2018-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-2018-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-2018-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-2018-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 | REMEDYREPACK INC. | 81d9e47e-ae81-4755-a5ee-546a038fadb4 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 7727fe84-f6cc-4b31-bc00-1ecf741ad361 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | d1b59d87-8442-4c15-8bb9-e39b198d8677 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | c2b38cc5-7738-44fa-9bef-89a18a1039b2 | 2025-12-03 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 1cc1a159-11ec-4040-817b-d57fa827a773 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 1fb26f9b-b075-471d-8cc3-fa39246ec2e4 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | beaa0678-e4b9-4241-8b08-e69e2e49530f | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | bd532a25-cfde-4c7d-8015-ba40609fb95c | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | d0cda063-00c5-0921-ee39-d4de1381f91a | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 55c5905c-6cb8-4ed4-8e69-97f733ca91b5 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Rising Pharma Holdings, Inc. | 58e9b4c6-531f-49c4-a640-6953e70892fe | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Aurolife Pharma LLC | aa05d606-29fd-443e-802b-1d65584d6bb1 | 2025-09-10 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Aurobindo Pharma Limited | a4c012f0-50b6-42fb-9f06-a14632f23f2e | 2025-07-19 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | ATLANTIC BIOLOGICALS CORP. | e6e5cbf7-a958-4ef8-abcc-a7491edb9520 | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Direct_Rx | 3699b988-6d9a-dcc1-e063-6394a90ab38d | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | NorthStar Rx LLC | 979eec8b-1bf4-466b-812e-85a111ce1cb5 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | American Health Packaging | 3b7a5f44-8da6-4196-bb5d-8d2770af1b3a | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Advanced Rx Pharmacy of Tennessee, LLC | f8c383c1-d1b3-ceaa-e053-6294a90a6053 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | NuCare Pharmaceuticals,Inc. | 8e839bb2-2f67-f224-e053-2a95a90ae5d8 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | NCS HealthCare of KY, LLC dba Vangard Labs | 70439462-b632-4d21-8067-560162db3137 | 2023-09-18 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |