Home Applications 020639 Application 020639
Type NDA
Sponsor ASTRAZENECA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Yes Yes 002 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Yes No 003 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Yes No 004 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 005 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Yes Yes 006 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Yes No 007 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020639-001 SEROQUEL QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 N020639-002 SEROQUEL QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 N020639-003 SEROQUEL QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 N020639-004 SEROQUEL QUETIAPINE FUMARATE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 N020639-005 SEROQUEL QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 N020639-006 SEROQUEL QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 N020639-007 SEROQUEL QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 8 · 301 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 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 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 · 2 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 2 of 2 · 85 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70518-2424 SEROQUEL Quetiapine fumarate REMEDYREPACK INC. NDA Current 70518-2424 SEROQUEL Quetiapine fumarate REMEDYREPACK INC. NDA Current 70518-2424 SEROQUEL Quetiapine fumarate REMEDYREPACK INC. NDA Current 70518-2828 SEROQUEL quetiapine REMEDYREPACK INC. NDA Current 70518-2828 SEROQUEL quetiapine REMEDYREPACK INC. NDA Current