Home Applications 072691 Application 072691
Type ANDA
Sponsor WATSON LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMOXAPINE AMOXAPINE TABLET;ORAL 150MG No Yes 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 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 A072691-001 AMOXAPINE AMOXAPINE 150MG TABLET / ORAL AB RS 1992-08-28 A072691-002 AMOXAPINE AMOXAPINE 25MG TABLET / ORAL AB 1992-08-28 A072691-003 AMOXAPINE AMOXAPINE 50MG TABLET / ORAL AB 1992-08-28 A072691-004 AMOXAPINE AMOXAPINE 100MG TABLET / ORAL AB 1992-08-28
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 2 of 5 · 176 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 2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072691-001 AMOXAPINE 150MG TABLET / ORAL RS 1992-08-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A072691-002 AMOXAPINE 25MG TABLET / ORAL 1992-08-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A072691-003 AMOXAPINE 50MG TABLET / ORAL 1992-08-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A072691-004 AMOXAPINE 100MG TABLET / ORAL 1992-08-28 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-5713 Amoxapine Amoxapine Actavis Pharma, Inc. ANDA Current 0591-5713 Amoxapine Amoxapine Actavis Pharma, Inc. ANDA Current 0591-5714 Amoxapine Amoxapine Actavis Pharma, Inc. ANDA Current 0591-5714 Amoxapine Amoxapine Actavis Pharma, Inc. ANDA Current 0591-5715 Amoxapine Amoxapine Actavis Pharma, Inc. ANDA Current 0591-5715 Amoxapine Amoxapine Actavis Pharma, Inc. ANDA Current 0591-5716 Amoxapine Amoxapine Actavis Pharma, Inc. ANDA Current 0591-5716 Amoxapine Amoxapine Actavis Pharma, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 18350 SUPPL 2014-09-05