Home Applications 021208 Application 021208
Type NDA
Sponsor ORGANON USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Yes Yes 002 REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG Yes No 003 REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021208-001 REMERON SOLTAB MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD, RS 2001-01-12 N021208-002 REMERON SOLTAB MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 N021208-003 REMERON SOLTAB MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 of 4 · 132 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 2022-10-28 04:53 UTC 2022-10 N021208-001 REMERON SOLTAB 15MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD, RS 2001-01-12 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021208-002 REMERON SOLTAB 30MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021208-003 REMERON SOLTAB 45MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021208-001 REMERON SOLTAB 15MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD, RS 2001-01-12 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021208-002 REMERON SOLTAB 30MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021208-003 REMERON SOLTAB 45MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021208-001 REMERON SOLTAB 15MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD, RS 2001-01-12 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021208-002 REMERON SOLTAB 30MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021208-003 REMERON SOLTAB 45MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021208-001 REMERON SOLTAB 15MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD, RS 2001-01-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021208-002 REMERON SOLTAB 30MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021208-003 REMERON SOLTAB 45MG TABLET, ORALLY DISINTEGRATING / ORAL AB RLD 2001-01-12 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0052-0106 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0106 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0106 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0106 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0106 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0108 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0108 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0108 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0108 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0108 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0110 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0110 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0110 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0110 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 0052-0110 REMERONSOLTAB MIRTAZAPINE Organon USA Inc. NDA Current 78206-156 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current 78206-156 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current 78206-156 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current 78206-158 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current 78206-158 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current 78206-158 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current 78206-159 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current 78206-159 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current 78206-159 REMERONSOLTAB MIRTAZAPINE Organon LLC NDA Current