Home Applications 020415 Application 020415
Type NDA
Sponsor ORGANON USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REMERON MIRTAZAPINE TABLET;ORAL 15MG Yes Yes 002 REMERON MIRTAZAPINE TABLET;ORAL 30MG Yes No 003 REMERON MIRTAZAPINE TABLET;ORAL 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020415-001 REMERON MIRTAZAPINE 15MG TABLET / ORAL AB RLD, RS 1996-06-14 N020415-002 REMERON MIRTAZAPINE 30MG TABLET / ORAL AB RLD 1996-06-14 N020415-003 REMERON MIRTAZAPINE 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table 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 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 32 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0052-0105 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0105 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0105 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0105 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0105 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0107 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0107 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0107 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0107 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0107 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0109 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-0109 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4364 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4364 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4364 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4364 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4364 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4365 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4365 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4365 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4365 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 0052-4365 REMERON MIRTAZAPINE Organon USA Inc. NDA Current 70518-0903 REMERON MIRTAZAPINE REMEDYREPACK INC. NDA Current 70518-0903 REMERON MIRTAZAPINE REMEDYREPACK INC. NDA Current 70518-2176 REMERON MIRTAZAPINE REMEDYREPACK INC. NDA Current 70518-2176 REMERON MIRTAZAPINE REMEDYREPACK INC. NDA Current 78206-160 REMERON MIRTAZAPINE Organon LLC NDA Current 78206-160 REMERON MIRTAZAPINE Organon LLC NDA Current 78206-160 REMERON MIRTAZAPINE Organon LLC NDA Current 78206-161 REMERON MIRTAZAPINE Organon LLC NDA Current 78206-161 REMERON MIRTAZAPINE Organon LLC NDA Current 78206-161 REMERON MIRTAZAPINE Organon LLC NDA Current