Home Applications 072879 Application 072879
Type ANDA
Sponsor UPSHER SMITH LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMOXAPINE AMOXAPINE TABLET;ORAL 150MG No No 002 AMOXAPINE AMOXAPINE TABLET;ORAL 25MG No No 003 AMOXAPINE AMOXAPINE TABLET;ORAL 50MG No No 004 AMOXAPINE AMOXAPINE TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A072879-001 AMOXAPINE AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 A072879-002 AMOXAPINE AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 A072879-003 AMOXAPINE AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 A072879-004 AMOXAPINE AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28
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.
Product history page 1 of 3 · 88 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 2026-09-14 22:38:34 2026-08 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072879-001 AMOXAPINE 150MG TABLET / ORAL AB 1991-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072879-002 AMOXAPINE 25MG TABLET / ORAL AB 1991-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072879-003 AMOXAPINE 50MG TABLET / ORAL AB 1991-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072879-004 AMOXAPINE 100MG TABLET / ORAL AB 1991-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072879-001 AMOXAPINE 150MG TABLET / ORAL 1991-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072879-002 AMOXAPINE 25MG TABLET / ORAL 1991-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072879-003 AMOXAPINE 50MG TABLET / ORAL 1991-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072879-004 AMOXAPINE 100MG TABLET / ORAL 1991-06-28 5bbf6a4d5a75…
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 Amoxapine AMOXAPINE Chartwell RX, LLC eed5e856-dd7b-4eaa-9dad-508f2bef9328 2024-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072879 application number: ANDA072879
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.