Home Applications 219721 Application 219721
Type ANDA
Sponsor ANNORA PHARMA Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219721-001 MIRTAZAPINE MIRTAZAPINE 7.5MG TABLET / ORAL AB 2025-10-02 A219721-002 MIRTAZAPINE MIRTAZAPINE 15MG TABLET / ORAL AB 2025-10-02 A219721-003 MIRTAZAPINE MIRTAZAPINE 30MG TABLET / ORAL AB 2025-10-02 A219721-004 MIRTAZAPINE MIRTAZAPINE 45MG TABLET / ORAL AB 2025-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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.
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 2026-10-15 13:18:30 2026-09 A219721-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2025-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219721-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2025-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219721-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2025-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219721-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2025-10-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219721-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2025-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219721-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2025-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219721-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2025-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219721-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2025-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219721-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2025-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219721-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2025-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219721-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2025-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219721-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2025-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219721-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2025-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219721-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2025-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219721-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2025-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219721-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2025-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219721-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2025-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219721-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2025-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219721-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2025-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219721-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2025-10-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219721-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2025-10-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219721-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2025-10-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219721-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2025-10-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219721-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2025-10-02 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join mirtazapine MIRTAZAPINE A-S Medication Solutions 222dfdde-6979-4b18-a7eb-ff1ad0a437c1 2026-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219721 application number: ANDA219721
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.